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Validation Engineer: Laboratory and Manufacturing Equipment

Hired by Matrix

Lexington, MA

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JOB DETAILS
SALARY
$57–$62 Per Hour
SKILLS
Autoclave, Calibration, Change Control, Chromatographic Systems, Chromatography, Commissioning, Consulting, Corporate Compliance, Current Good Manufacturing Practice (cGMP), Data Analysis, Data Collection, Documentation, Equipment Maintenance/Repair, FDA (Food and Drug Administration), Failure Analysis, Installation Guide, Laboratory Equipment, Manufacturing, Manufacturing Equipment, Manufacturing Operations, Manufacturing/Industrial Processes, Operational Audit, Performance Analysis, Process Validation, Product Lifecycle, Project Development, Project Planning, Requirements Management, Risk, Standard Operating Procedures (SOP), Technical Recruiting, Test Plan/Schedule, Test Strategy, Testing, Validation Documentation, Validation Plan
LOCATION
Lexington, MA
POSTED
4 days ago
At-a-Glance:
re you ready to build your career by joining a certified technology solutions and compliance consulting services company.  If so, our client is hiring a Validation Engineer: Laboratory and Manufacturing Equipment.

Position Type:
  • Contract
  • Onsite
Required
  • Experience as Validation Engineer: Laboratory and Manufacturing Equipment.
Responsibilities:
  • Authoring and execution of Commissioning test plans (CTP) for new and modified systems/equipment including Chromatography skids, Temperature Controlled units, Ultrafiltration/Diafiltration Skids, Totes, columns and bioreactors.
  • Authoring Installation, Operational, and performance Qualification (IOPQ) protocols per Food and Drug Administration (FDA)/ company guidelines.
  • Drafting, reviewing, receipt and addressing of comments to approve validation documentation in compliance with FDA and company guidelines.
  • Validate laboratory and manufacturing equipment and processes such as Chromatography systems, Stability System, Empower, Soft Max Pro, Incubators, Spectrophotometers, Plate Readers, Autoclaves and other equipment.
  • Execution of approved protocols per company Good Documentation Practice (GDP) Current Good Manufacturing practice (cGMP), and applicable current industry guidance.
  • Study new product characteristics based on process transfer protocols and define validation deliverables/strategy for all impacted procedures in the product manufacturing lifecycle.
  • Draft validation project/master plans, including roles and responsibilities, and testing strategies.
  • Develop project plan summary reports to maintain and track all associated validation protocols, reports, and engineering test plans with change control records.
  • Identifies discrepancies that have occurred during execution of IOPQ protocols during manufacturing and laboratory equipment qualification.
  • Identifies impact of the discrepancies on protocol, equipment, or product.
  • Perform failure analysis processes and documentation for discrepancies.
  • Review manufacturing operational use SOPs that apply to validated equipment and processes.
  • Review master batch records to ensure alignment with specified procedures and
  • process transfer protocols.
  • Draft and review technical specifications including user requirement specifications (URS) and Functional Requirement Specification (FRS).
  • Perform Parameter mapping studies for applicable units to gauge performance and gather necessary data.
  • Based on study data, suggest mitigation efforts for potential safety issues and deviations.
  • Based on scientific data analysis, develop risk-based approaches for future studies and challenge the status quo to increase operational efficiency.
  • Perform calibration activities and maintain the equipment logs for the equipment to use in validation activities and verify the calibration data for the equipment.
  • Manage, review/approval process for validation documents in company electronic document repository and ensure detailed logs books are maintained for audit readiness.
Get in Touch:
We want to hear from you! If you think you’d be a good match, submit your resume and reach out to Komal at (862) 390-7418 to learn more.

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About the Company

H

Hired by Matrix

We believe in putting people together for the right reasons. Getting you a great job that makes you feel fulfilled in your career. Finding the perfect candidate to help you achieve business success. Whether you are looking for the best candidate for your company or searching for your next career move, we are dedicated to making sure you thrive. We take your needs personally and have a variety of services to ensure you reach your goals. We listen to the needs of our clients and candidates and then thoughtfully match the right person with the right job. When people come together doing what they love success is guaranteed and partnerships last.
COMPANY SIZE
100 to 499 employees
INDUSTRY
Staffing/Employment Agencies
WEBSITE
http://www.hiredbymatrix.com

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