Validation Engineer II

Job title: Validation Engineer II

Location: Carlsbad CA 92008

Duration: 06 Month

Main Purpose of the Role:

• Responsible for creating and implementing the Division validation program. Creates and maintains validation documentation for new and existing systems and processes subject to design control.
• Ensures that validation activities are implemented for systems and processes used to manufacture, control and store intermediates and finished products to requirements and standards as listed in the current Quality Systems Manual.

Main Responsibilities:

• Develop and execute validation strategies for GMP facilities, utilities, process equipment, analytical instruments, and laboratory systems
• Author and execute Validation Master Plans (VMPs), equipment validation plans, and qualification strategies using a risk-based approach aligned with internal procedures and regulatory expectations
• Manage VMPs and associated reports related to new product development and existing production processes, systems, and controls
• Develop and/or review User Requirements Specifications (URS), functional requirements, risk assessments, and Requirements Traceability Matrices (RTMs) for new and existing systems
• Author protocols for Process Validations and Facilities, Utilities, Equipment and/or analytical instrumentation qualification including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Engineering Study Protocols (ESPs), and associated lifecycle documentation against production processes and systems in compliance to internal and external requirements utilizing well developed technical and regulatory skills
• Lead or support execution of IQ, OQ, PQ, Test Method Validation (TMV), Engineering Studies, and Process Validation activities for manufacturing processes, facilities, utilities, and equipment
• Manage the execution of validation protocols, as protocol directors, in assurance of timely and cost efficient completion through specialized experience and training
• Evaluate validation results of validation protocol executions employing specialized experience and training
• Consult with owner/user groups to summarize validation results in final reports incorporating strong communication skills and experience
• Support equipment commissioning, installation verification, startup activities, and turnover into GMP operation for manufacturing and laboratory systems
• Perform validation assessment on Change Management documentation including, but not limited to document changes, system changes, and process changes
• Track and report validation progress of corporate validation projects through departmental project tracking tools
• Evaluate qualification and validation results, investigate deviations and validation events, author validation event reports (VERFs), and implement corrective actions as required
• Represent Division during internal and external audits of validation projects and documentation
• Present validation and qualification status, results, and release recommendations during project reviews
• Cultivates a wide range of internal networks and begins to develop an extensive external network of resources to facilitate completion of tasks
• May lead a project team of moderate scope
• Provides guidance to less experienced staff
• Acts as a mentor to lower level individual contributors
• Influence exerted at peer level and occasionally at first levels of management
• Plans, organizes, and prioritizes own daily work routine to meet established schedule
• Execises authority and judgment within defined limits to determine appropriate action
• Failure to achieve results or erroneous decisions or recommendations may cause delays in program schedules and may result in the allocation of additional resources

QUALIFICATIONS

• Education Level Major/Field of Study or Equivalent
• Bachelors Degree in related field
• Masters Degree Preferred
• Preferred experience and technical skills:
• Strongly preferred experience in one or more of the following areas:
• Qualification and validation of GMP manufacturing equipment used in oligonucleotide, biologics, or biotechnology manufacturing environments
• Hands-on experience serving as validation lead qualifying analytical instrumentation including Agilent HPLC systems (OpenLab CDS), chromatography data systems, spectrophotometers, and other laboratory analytical equipment
• Experience qualifying and validating automated purification systems including Cytiva ÄKTA Pure, ÄKTA Go, ÄKTA Flux, tangential flow filtration (TFF), and chromatography platforms utilizing UNICORN software
• Experience with oligonucleotide synthesis equipment such as Cytiva ÄKTA OligoSynt or similar automated synthesis platforms
• Demonstrated experience independently planning and leading commissioning, qualification, and GMP readiness activities for new manufacturing facilities, cleanrooms, laboratories, utilities, process equipment, and infrastructure systems
• Demonstrated experience independently developing and executing validation strategies and lifecycle documentation for GMP facilities, utilities, equipment, and manufacturing processes, including Validation Master Plans (VMPs), User Requirements Specifications (URS), Requirements Traceability Matrices (RTMs), risk assessments, IQ/OQ/PQ protocols, engineering studies, process validation protocols, validation reports, and final validation turnover packages
• Experience managing validation through the full lifecycle from commissioning and qualification planning through equipment release, process validation, change control, deviation investigations, and ongoing validated-state maintenance
• Experience collaborating with equipment vendors during commissioning and qualification activities including evaluating vendor documentation to develop wrapper protocols aligning with site qualification standards and Quality Management System requirements.

Experience/background details:

• Minimum 2-3 years of related work experience with a good understanding of specified functional area.
• Working technical knowledge and application of concepts, practices and procedures.
• General understanding of business unit/group function.
• Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.
• Works on problems of moderate scope where analysis of situations or data requires a review of identifiable factors.
• Exercises judgment within defined procedures and practices to determine appropriate action.
• Has a broad knowledge of technical alternatives and an understanding of their impact on the systems environment