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UNKNOWN

This role partners with engineers and cross-functional teams to execute project tasks and contribute to the development of products that meet customer requirements for quality, performance, and timelines. This position provides hands-on experience in a laboratory and light manufacturing environment, offering exposure to medical device design, prototyping, testing, and documentation within a regulated environment.

The Engineering Intern supports the design, development, and transfer of medical devices across a range of applications including vascular, structural heart, and other interventional therapies. This role partners with engineers and cross-functional teams to execute project tasks and contribute to the development of products that meet customer requirements for quality, performance, and timelines.This position provides hands-on experience in a laboratory and light manufacturing environment, offering exposure to medical device design, prototyping, testing, and documentation within a regulated environment. Key Responsibilities<ul><li>Follow Aptyx Quality System, including all applicable SOPs and training requirements </li><li>Support development activities across the product lifecycle from concept through production </li><li>Assist with hands-on product assembly, prototyping, and process development (e.g., catheter-based devices) </li><li>Support engineers in designing components, fixtures, and tooling using CAD software (SolidWorks preferred) </li><li>Conduct testing and support verification and validation activities, including data collection and documentation </li><li>Assist in developing and documenting manufacturing processes, work instructions, and procedures </li><li>Participate in feasibility studies, experimentation, and engineering evaluations </li><li>Support equipment setup, basic maintenance, and troubleshooting under supervision </li><li>Prepare and maintain documentation in accordance with quality system requirements, including: <ul><li>Test protocols and reports </li><li>Engineering drawings </li><li>Work instructions </li></ul></li><li>Communicate progress, issues, and results to project teams </li><li>Collaborate with internal teams and external vendors as needed </li><li>Participate in team meetings and contribute to problem-solving discussions </li><li>Support manufacturing and engineering teams on active programs </li></ul> Qualifications / Education<ul><li>Currently pursuing a BS or MS in Biomedical Engineering, Mechanical Engineering, or a related field </li></ul> Experience, Skills, and Abilities<ul><li>Prior internship, co-op, or hands-on academic project experience preferred </li><li>Familiarity with CAD software (SolidWorks preferred) </li><li>Strong mechanical aptitude and hands-on skills </li><li>Basic understanding of engineering principles, materials, and manufacturing concepts </li><li>Strong analytical and problem-solving skills </li><li>Effective verbal and written communication skills </li><li>Proficiency with Microsoft Office tools </li><li>Experience using basic hand tools (e.g., calipers, screwdrivers, measurement devices) </li></ul> Core Competencies<ol><li> Learning Agility & Curiosity</li></ol><ul><li>Demonstrates eagerness to learn new tools, technologies, and processes </li><li>Actively seeks feedback and applies it to improve performance </li><li>Adapts quickly in a fast-paced, hands-on environment </li></ul><ol start="2"><li> Technical & Hands-On Aptitude</li></ol><ul><li>Applies basic engineering principles to solve problems </li><li>Demonstrates comfort working with tools, components, and lab equipment </li><li>Shows attention to detail in assembly, testing, and documentation </li></ul><ol start="3"><li> Problem Solving & Analytical Thinking</li></ol><ul><li>Approaches problems methodically with data-driven thinking </li><li>Supports root cause investigations and experimentation </li><li>Identifies issues and escalates appropriately </li></ul><ol start="4"><li> Communication & Team Collaboration</li></ol><ul><li>Communicates clearly with engineers, technicians, and cross-functional teams </li><li>Actively participates in team discussions and meetings </li><li>Shares progress, challenges, and results effectively </li></ul><ol start="5"><li> Accountability & Work Ethic</li></ol><ul><li>Takes ownership of assigned tasks and meets deadlines </li><li>Demonstrates reliability and professionalism </li><li>Follows through on commitments with quality output </li></ul><ol start="6"><li> Quality & Compliance Mindset</li></ol><ul><li>Understands and adheres to regulated environment requirements </li><li>Maintains accurate and complete documentation </li><li>Demonstrates attention to detail and commitment to quality </li></ul> Physical Demands of PositionThe physical demands described here are representative of those that must be met to successfully perform the essential functions of this role. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.This role requires sitting, standing, and the use of hands and arms for routine tasks such as computer use, assembly work, and handling tools and materials. The position operates in both laboratory and manufacturing environments, where variable conditions may exist. Normal vision, hearing, and communication abilities are required for effective collaboration.This description is not intended to be an exhaustive list of responsibilities or requirements. Aptyx reserves the right to modify duties and responsibilities as business needs evolve. Measurement of Performance<ul><li>Adherence to Aptyx Quality System and documentation practices </li><li>Timely completion of assigned tasks with appropriate quality </li><li>Effectiveness of communication and teamwork </li><li>Demonstrated growth in technical and hands-on engineering skills </li><li>Contribution to project team objectives and deliverables</li></ul>

Aptyx

Engineering Intern

Analysis Skills

Biomedical Engineering

CAD (Computer-Aided Design) Software

Catheterization

Communication Skills

Cross-Functional

Data Collection

Detail Oriented

Documentation

Engineering

Engineering Drawing

Environmental Regulations

Feasibility Analysis

Hand Tools

Identify Issues

Laboratory

Laboratory Equipment

Machine Tool

Manufacturing

Manufacturing/Industrial Processes

Mechanical Engineering

Medical Equipment

Microsoft Office

Performance Management

Physical Demands

Presentation/Verbal Skills

Problem Solving Skills

Process Development

Product Development

Product Lifecycle

Prototyping

Quality System Requirements (QSR)

Root Cause Analysis

SolidWorks

Standard Operating Procedures (SOP)

Team Player

Technical Support

Testing

Time Management

Validation Testing

Writing Skills

Talent Acquisition

OTHER

The Transfer Engineer will work cross-functionally with Operations, Quality, Supply Chain, and customers to deliver robust, scalable, and cost-effective manufacturing processes. This role spans early-career to mid-level engineering capability, with increasing responsibility for process development, validation, equipment implementation, and customer engagement.

The Transfer Engineer I–II plays a key role in supporting and leading the transfer of interventional and transcatheter medical devices from development into production. This position contributes to Aptyx's end-to-end solutions for Class II and III medical devices, including implants, catheters, and other disposable products.This role spans early-career to mid-level engineering capability, with increasing responsibility for process development, validation, equipment implementation, and customer engagement. The Transfer Engineer will work cross-functionally with Operations, Quality, Supply Chain, and customers to deliver robust, scalable, and cost-effective manufacturing processes. Duties and ResponsibilitiesQuality System & Compliance<ul><li>Follow the Aptyx Quality System and all applicable SOPs within the Training Matrix. </li><li>Ensure compliance with medical device regulations and internal validation standards. </li></ul>Process Development & Manufacturing Transfer<ul><li>Support (Level I) and lead (Level II) hands-on process development of catheters, implants, and disposable medical devices. </li><li>Assist (I) or independently develop (II) pilot and manufacturing equipment, processes, and procedures. </li><li>Support (I) and lead (II) equipment acquisition, setup, and installation qualification (IQ). </li><li>Execute design changes and support product line transfers into production. </li></ul>Validation & Risk Management<ul><li>Contribute to (I) and independently plan/execute (II) validation activities including IQ, OQ, PQ, TMV, Gage R&R, and MSA. </li><li>Support (I) and lead (II) development and maintenance of pFMEAs and Master Validation Plans (MVPs). </li><li>Ensure validation documentation is accurate, complete, and audit-ready. </li></ul>Production Support & Continuous Improvement<ul><li>Support production builds, line setup, troubleshooting, and training activities. </li><li>Lead (II) or contribute (I) to Lean and Six Sigma initiatives to reduce waste and improve efficiency. </li><li>Conduct time studies, capacity analysis, and layout optimization to improve throughput. </li><li>Analyze COGS and identify cost-reduction opportunities. </li></ul>Design for Manufacturability (DFM)<ul><li>Participate in (I) and lead (II) DFM discussions with R&D. </li><li>Recommend design improvements to enhance manufacturability, yield, and cost. </li></ul>Supplier & Material Management<ul><li>Coordinate with suppliers on material specifications, validations, and quality issues. </li><li>Support (I) or lead (II) supplier validations and material change processes. </li></ul>Customer & Cross-Functional Collaboration<ul><li>Communicate project status, risks, and technical updates to customers. </li><li>Escalate issues appropriately (I) or independently manage customer communication (II). </li><li>Collaborate with cross-functional teams including Operations, Quality, and Supply Chain. </li></ul>Documentation & Systems<ul><li>Review and update manufacturing documentation (work instructions, BOMs, routings). </li><li>Maintain ERP data and engineering change orders. </li><li>Write and review test methods and validation protocols. </li></ul>Project Execution<ul><li>Support (I) or lead (II) project execution, ensuring alignment to timelines, scope, and budget. </li><li>Demonstrate increasing ownership and decision-making responsibility at Level II. </li></ul> Qualifications<ul><li>Background in disposable medical device design, development, and manufacturing. </li><li>Knowledge of materials, prototyping, and manufacturing processes. </li><li>Project management experience preferred (increasing expectation at Level II). </li></ul> Education<ul><li>Bachelor's or Master's degree in Biomedical Engineering, Mechanical Engineering, or related field required. </li></ul> Experience<ul><li>Level I: 1+ years of relevant engineering experience (medical device preferred) </li><li>Level II: 2–5 years of experience in medical device engineering or manufacturing </li><li>Experience with SolidWorks or equivalent CAD software preferred. </li></ul> Skills, Knowledge, and Abilities<ul><li>Proficiency in MS Office, CAD (SolidWorks), and ERP systems </li><li>Understanding of medical device regulations and validation methodologies </li><li>Strong analytical and problem-solving skills </li><li>Effective communication and collaboration skills </li><li>Ability to manage multiple priorities in a fast-paced environment </li><li>Experience with Lean Manufacturing and Six Sigma tools (preferred for Level II) </li></ul> Competencies<ol><li> Technical & Engineering Excellence</li></ol><ul><li>Level I: Applies foundational engineering principles; executes tasks with guidance </li><li>Level II: Independently develops processes and solves complex technical problems </li></ul><ol start="2"><li> Validation & Quality Mindset</li></ol><ul><li>Level I: Supports validation execution and documentation </li><li>Level II: Leads validation strategy and ensures compliance and robustness </li></ul><ol start="3"><li> Project Ownership & Execution</li></ol><ul><li>Level I: Contributes to project tasks and meets assigned deadlines </li><li>Level II: Owns project deliverables, timelines, and execution with minimal oversight </li></ul><ol start="4"><li> Continuous Improvement & Lean Thinking</li></ol><ul><li>Level I: Identifies inefficiencies and supports improvement initiatives </li><li>Level II: Leads Lean projects and drives measurable operational improvements </li></ul><ol start="5"><li> Collaboration & Communication</li></ol><ul><li>Level I: Communicates effectively within team; escalates issues appropriately </li><li>Level II: Independently interfaces with customers and leads cross-functional alignment </li></ul><ol start="6"><li> Business & Cost Acumen</li></ol><ul><li>Level I: Understands basic cost drivers and supports cost tracking </li><li>Level II: Analyzes COGS and implements cost reduction strategies </li></ul><ol start="7"><li> Problem Solving & Decision Making</li></ol><ul><li>Level I: Uses structured problem-solving with guidance </li><li>Level II: Leads root cause analysis and implements sustainable corrective actions </li></ul> Measurement of Performance<ul><li>Execution of projects on time and within scope </li><li>Quality and compliance of validation and engineering documentation </li><li>Contribution to process improvements and cost savings </li><li>Effectiveness in cross-functional collaboration and communication </li><li>Customer satisfaction and responsiveness </li><li>Demonstrated growth in technical capability and ownership </li></ul> Physical Demands of PositionThe physical demands described are representative of those required to successfully perform the essential functions of this role. Reasonable accommodations may be made.This position requires sitting, standing, and use of hands for computer and laboratory tasks. The role operates in both laboratory and manufacturing environments with variable conditions. Effective communication (verbal and written) and standard vision/hearing capabilities are required.

Transfer Engineer I-II

Bill of Materials (BOM)

Budgeting

CAD/CAM (Computer-Aided Design/Computer-Aided Manufacturing)

Capacity Analysis

Continuous Improvement

Corrective Action

Cost Control

Cost of Goods Sold (COGS)

Customer Relations

Customer Satisfaction

ERP (Enterprise Resource Planning)

Engineering Change Order

Equipment Validation

Implants

Lean Manufacturing

Lean Six Sigma

Maintain Compliance

Manufacturing Cost

Manufacturing Design

Manufacturing Equipment

Materials Management

Medical Disposables

Multitasking

Operational Improvement

Operational Measurement

Process Improvement

Process Manufacturing

Process Validation

Product Support

Production Support

Project Execution

Project/Program Management

Quality Assurance Methodology

Regulations

Regulatory Compliance

Research & Development (R&D)

Risk Management

Supply Chain

Test Plan/Schedule

Validation Documentation

Validation Plan

The Engineer II works with moderate independence to execute engineering tasks, support project deliverables assigned by the Project Manager, and communicate technical status updates to cross-functional teams. The R&D Engineer II performs design engineering functions in support of medical device product development programs across multiple therapeutic areas including cardiology, neurology, and urology.

The R&D Engineer II performs design engineering functions in support of medical device product development programs across multiple therapeutic areas including cardiology, neurology, and urology. This role contributes to projects from concept through commercialization, ensuring deliverables meet customer requirements for quality, cost, and schedule performance.The Engineer II works with moderate independence to execute engineering tasks, support project deliverables assigned by the Project Manager, and communicate technical status updates to cross-functional teams. Updates may include technical feasibility, schedule impact, budget considerations, and risk to project objectives.This role also supports development of engineering processes, manufacturing readiness, and continuous improvement of product and design solutions within a regulated environment. Key ResponsibilitiesProduct Design & Development<ul><li>Follow the Aptyx Quality System, including all applicable SOPs and training requirements </li><li>Develop and engineer medical devices from concept through production with little supervision </li><li>Perform hands-on product assembly and process development for catheters and other medical devices </li><li>Design devices, components, tooling, and fixtures using SolidWorks or equivalent CAD software </li><li>Build prototypes and support laboratory-based development activities </li><li>Engage with senior and principal engineers for technical guidance as needed </li></ul> Manufacturing & Process Development<ul><li>Design and develop pilot and production tooling, fixtures, equipment, and manufacturing procedures with limited supervision </li><li>Support installation, setup, and qualification of new equipment, including development of preventive maintenance (PM) procedures as needed </li><li>Perform or support equipment maintenance and coordinate re-entry to production use, escalating issues to the Technology Manager when appropriate </li><li>Assess process feasibility and support manufacturing with validation planning and time studies </li><li>Develop manufacturing methods and support product transition into full production </li></ul>  Validation, Testing & Documentation<ul><li>Develop and execute verification and validation activities with limited supervision, including testing and documentation </li><li>Prepare engineering documentation to support the quality system, including: <ul><li>Test results and data analysis </li><li>Engineering drawings </li><li>Test reports </li></ul></li><li>Ensure compliance with good documentation practices and regulatory requirements </li><li>Support engineering changes and updates to existing product lines as needed </li></ul> Project Support & Communication<ul><li>Communicate directly with project teams and leadership regarding task status, risks, and technical challenges </li><li>Support execution of project deliverables assigned by the Project Manager </li><li>Provide input on technical feasibility, schedule, and budget impacts </li><li>Demonstrate understanding of the design and development (D&D) process through execution of assigned work </li><li>Support manufacturing and product development activities through commercialization </li></ul> Vendor & Cross-Functional Collaboration<ul><li>Collaborate with external vendors on sourcing of materials, components, tooling, and manufacturing processes </li><li>Support engineering teams in investigations related to customer complaints and product issues </li><li>Work cross-functionally with Quality, Manufacturing, Supply Chain, and Project Management teams </li></ul> Education<ul><li>Bachelor's or Master's degree in Biomedical Engineering, Mechanical Engineering, or related discipline required </li></ul> Experience<ul><li>3+ years of engineering experience in medical device development or regulated manufacturing environment </li><li>Experience with catheter-based or complex medical device development strongly preferred </li></ul> Skills & Qualifications<ul><li>Proficiency in SolidWorks or equivalent CAD software </li><li>Strong experience in hands-on prototyping and mechanical assembly </li><li>Knowledge of medical device materials and manufacturing processes (e.g., thermal bonding, PTFE processing, fixture design, etc.) </li><li>Familiarity with validation (IQ/OQ/PQ), design controls, and regulated product development processes </li><li>Strong analytical and problem-solving skills </li><li>Excellent verbal and written communication skills </li><li>Proficiency in Microsoft Office Suite </li><li>Ability to use basic hand tools (drills, screwdrivers, wrenches, saws, etc.) </li><li>Familiarity with multiple manufacturing methods used in device production </li></ul> Physical Requirements<ul><li>Ability to work in both laboratory and manufacturing environments with variable conditions </li><li>Frequent use of hands, arms, and fingers for engineering and technical tasks </li><li>Ability to sit, stand, and move throughout production and lab environments </li><li>Normal vision and hearing required for communication and technical work </li><li>Must be able to effectively communicate in person, electronically, and via phone </li></ul> Performance Expectations<ul><li>Adherence to the Aptyx Quality System and SOP compliance requirements </li><li>Timely and accurate completion of engineering deliverables and documentation </li><li>Clear and proactive communication of task status, risks, and technical issues </li><li>Consistent on-time and on-budget execution of assigned work </li><li>Proficiency in SolidWorks and adherence to internal drawing/documentation standards </li><li>Demonstrated understanding of multiple medical device manufacturing technologies (e.g., bonding, fixture design, PTFE processing, etc.) </li><li>Strong understanding of the design and development (D&D) process and its impact on project execution </li><li>Demonstrated growth in technical capability, independence, and problem-solving ability</li></ul>

R&D Engineer Associate Level - Level II

Budget Management

Cardiology

Documentation Standards

Equipment Maintenance/Repair

Leadership

Manufacturing Methods

Manufacturing Technology

Mechanical Assembly

Medical Products

Neurology

Preventative Maintenance

Process Analysis

Product Design

Production Systems

Risk

Supply Chain Management

Support Documentation

Technical Leadership

Technical/Engineering Design

Urology

Vendor/Supplier Sourcing

The Engineer II – Senior R&D Engineer performs design engineering and technical leadership within the Development organization, supporting the development of Class II and Class III medical devices across multiple therapeutic areas including cardiology, neurology, and urology. Engineer II-level employees operate with moderate supervision, while Senior Engineers lead technical execution, mentor team members, and drive project outcomes with minimal oversight.

The Engineer II – Senior R&D Engineer performs design engineering and technical leadership within the Development organization, supporting the development of Class II and Class III medical devices across multiple therapeutic areas including cardiology, neurology, and urology.This role supports or leads cross-functional project teams from concept through commercialization, ensuring delivery of customer requirements for quality, cost, and timeline objectives. The engineer contributes to or leads technical execution, communicates project status, and ensures engineering deliverables align with regulatory and quality system requirements.Engineer II-level employees operate with moderate supervision, while Senior Engineers lead technical execution, mentor team members, and drive project outcomes with minimal oversight.<hr/><h2>Key Responsibilities</h2><h3>Product Development & Engineering Execution</h3><ul><li>Follow Aptyx Quality System, including all applicable SOPs and training requirements</li><li>Design and develop medical devices from concept through production with increasing independence based on level (Engineer II vs Senior)</li><li>Lead or support hands-on development of catheters and other medical devices, including assembly and prototyping</li><li>Design components, devices, tooling, and fixtures using SolidWorks or equivalent CAD software</li><li>Build prototypes and support laboratory development activities</li><li>Develop and refine manufacturing methods, processes, and procedures through commercialization</li></ul><hr/><h3>Process Development & Manufacturing Support</h3><ul><li>Develop pilot and production tooling, fixtures, equipment, and assembly processes</li><li>Support installation, qualification, and validation of new equipment</li><li>Create and maintain preventive maintenance procedures as needed</li><li>Perform or lead feasibility assessments, process development, and time studies</li><li>Support manufacturing with troubleshooting, process improvements, and re-entry-to-line activities</li><li>Escalate complex equipment or process issues to Technology Manager as appropriate</li></ul><hr/><h3>Validation, Testing & Documentation</h3><ul><li>Develop and/or lead verification and validation activities, including test planning, execution, and reporting</li><li>Prepare technical documentation to support design control requirements, including:<ul><li>Test protocols and reports</li><li>Engineering drawings</li><li>Design history file documentation</li></ul></li><li>Ensure compliance with good documentation practices and regulatory requirements</li><li>Support design changes and product updates for existing product lines</li></ul><hr/><h3>Project & Technical Leadership</h3><ul><li>Communicate project status, risks, technical feasibility, and resource needs to project teams and leadership</li><li>Support or lead project schedules, deliverables, and technical execution depending on level</li><li>Collaborate with cross-functional teams including Quality, Manufacturing, Supply Chain, and Project Management</li><li>Engage with senior engineers, principal engineers, and leadership for technical guidance and alignment</li><li>Lead or support customer complaint investigations and corrective actions</li></ul><hr/><h3>Vendor & External Collaboration</h3><ul><li>Collaborate with external vendors on materials, components, tooling, and manufacturing processes</li><li>Support or lead supplier technical discussions and development activities</li><li>Assist in quotation and technical input for new product development opportunities (Senior level responsibility)</li></ul><hr/><h3>Leadership (Senior Level Emphasis)</h3><ul><li>Lead engineering deliverables and technical execution of projects</li><li>Mentor and support development of junior engineers and team members</li><li>Drive resolution of complex technical challenges with minimal supervision</li><li>Support resource planning, budgeting, and technical input into project planning activities</li><li>Contribute to continuous improvement of engineering practices and design standards</li></ul><hr/><h2>Education</h2><ul><li>BS or MS in Biomedical Engineering, Mechanical Engineering, or related discipline required</li></ul><hr/><h2>Experience</h2>Engineer II:<ul><li>3+ years of experience in medical device engineering or related field</li></ul>Senior Engineer:<ul><li>6+ years of experience in medical device engineering or related field</li></ul><hr/><h2>Skills & Qualifications</h2><ul><li>Strong experience in medical device design and development</li><li>Proficiency in SolidWorks or equivalent CAD software</li><li>Hands-on prototyping and lab-based engineering experience</li><li>Strong knowledge of materials and manufacturing processes (e.g., thermal bonding, PTFE processing, fixture design, etc.)</li><li>Experience with validation (IQ/OQ/PQ) and design controls</li><li>Strong analytical and problem-solving skills</li><li>Excellent verbal and written communication skills</li><li>Proficiency in Microsoft Office Suite</li><li>Familiarity with hand tools and manufacturing equipment</li></ul><hr/><h2>Physical Requirements</h2><ul><li>Ability to work in both laboratory and manufacturing environments</li><li>Regular use of hands, arms, and fingers for engineering and computer work</li><li>Ability to sit, stand, and move within production and lab environments</li><li>Normal vision and hearing required for documentation and communication</li><li>Must be able to effectively communicate in person, electronically, and by phone</li></ul><hr/><h2>Performance Expectations</h2><ul><li>Adherence to Aptyx Quality System and SOPs</li><li>Timely and accurate completion of engineering documentation and deliverables</li><li>Ability to clearly communicate project status, risks, and technical challenges</li><li>Quality and completeness of design outputs and documentation</li><li>On-time and on-budget execution of assigned project responsibilities</li><li>Demonstrated proficiency in SolidWorks and engineering drawing standards</li><li>Understanding and application of the design and development (D&D) process</li><li>Demonstrated progression in technical depth, autonomy, and leadership based on level</li></ul><hr/>

R&D Engineer Level II-Senior

Assembly Equipment

Customer Support/Service

Mentoring

Product Engineering

Project Planning

Project Schedule

Software Design

Software Development

Team Lead/Manager

Technical Delivery

Technical Writing

The ideal candidate will collaborate with Manufacturing, Quality Assurance, Engineering, and Regulatory teams to support production operations, maintain validated systems, and ensure regulatory compliance across the facility. Bachelor's degree in Chemical Engineering, Mechanical Engineering, Biomedical Engineering, Biotechnology, or related field .

Job Title: Validation Engineer Location: Concord, NC Duration: Long TermJob SummaryWe are seeking a motivated and detail-oriented Validation Engineer to support validation activities within a GMP-regulated biopharmaceutical manufacturing environment. The Validation Engineer will be responsible for equipment qualification, process validation, utility validation, and cleaning validation activities to ensure compliance with FDA, cGMP, and industry standards.The ideal candidate will collaborate with Manufacturing, Quality Assurance, Engineering, and Regulatory teams to support production operations, maintain validated systems, and ensure regulatory compliance across the facility.Key Responsibilities<ul><li>Develop, execute, and review validation protocols and reports including IQ, OQ, and PQ documentation </li><li>Support equipment qualification activities for biopharmaceutical manufacturing equipment and laboratory systems </li><li>Perform process validation for upstream and downstream manufacturing processes </li><li>Execute cleaning validation and utility qualification activities including HVAC, purified water, compressed gases, and cleanroom systems </li><li>Ensure compliance with FDA, cGMP, GDP, and company quality standards </li><li>Support computerized systems validation (CSV) activities when required </li><li>Participate in deviation investigations, root cause analysis, CAPA, and change control processes </li><li>Collaborate with cross-functional teams during equipment installation, commissioning, and technology transfer projects </li><li>Maintain validation lifecycle documentation including SOPs, Validation Master Plans (VMP), and risk assessments </li><li>Assist during internal audits and regulatory inspections by providing validation documentation and technical support </li><li>Identify and implement continuous improvement opportunities within validation and manufacturing processes </li></ul>Required Qualifications<ul><li>Bachelor's degree in Chemical Engineering, Mechanical Engineering, Biomedical Engineering, Biotechnology, or related field </li><li>3+ years of validation experience in biopharmaceutical, pharmaceutical, or regulated manufacturing industries </li><li>Strong understanding of cGMP, FDA regulations, and validation principles </li><li>Experience with IQ/OQ/PQ protocol execution and report generation </li><li>Knowledge of process validation, cleaning validation, and utility qualification </li><li>Familiarity with deviation management, CAPA, and change control systems </li><li>Strong technical writing and documentation skills </li><li>Excellent communication, analytical, and problem-solving abilities</li></ul>

Stark Pharma Solutions Inc

Validation Engineer

Biotech and Pharmaceutical

Change Control

Chemical Engineering

Cleanroom

Commissioning

Control Systems

Corrective and Preventative Action (CAPA) Systems

Current Good Manufacturing Practice (cGMP)

FDA (Food and Drug Administration)

FDA Requirements

GMP (Good Manufacturing Practices)

HVAC

Industry Standards

Internal Audit

Laboratory Systems

Operational Support

Quality Assurance

Quality Engineering

Quality Metrics

Risk Analysis

System Validation

Systems Maintenance

Ceipal

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Engineering InternAptyx

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R&D Engineer Associate Level - Level IIAptyx

R&D Engineer Level II-SeniorAptyx

Validation EngineerStark Pharma Solutions Inc

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