ELIQUENT Life Sciences
QC Method Validation Engineer
ELIQUENT Life Sciences, Thousand Oaks, California, United States, 91362
ELIQUENT Life Sciences is the leading global consulting firm providing solutions to life science companies researching, developing, and manufacturing innovative products to serve patients and respond to public health challenges around the world. ELIQUENT is committed to serving clients’ needs with extensive expertise, unwavering integrity, and strategic insight in a manner that supports availability of safe, effective, and high-quality drugs, biologics, and medical devices.
We are seeking a
QC Method Validation Engineer
to join our team. The role involves validation of quality control instruments, review of turnover packages, and update of instrument operations and maintenance Standard Operating Procedures (SOPs). Validation of quality control instruments including the following: HPLC, GC, UV-Vis, FTIR, Dissolution, TOC analyzers, Microscope, Refrigerated Centrifuge, Microplate Shaker, Vortex Mixer, etc. Review of turnover packages (TOPs) and applicable work instructions Review and update User Requirements Specifications (URS) and generate system design and configuration specifications Review and update instrument operations and maintenance Standard Operating Procedures (SOPs) Complete Equipment Classification(s) & Calibration forms Manage/support vendor instrument IOQ process and develop/execute appropriate PQ protocols Author PQ final reports including trace matrices and data integrity assessments Develop Transfer/Validation/Verification protocols for QC Analytical Methods Develop method SOPs for multiple materials Demonstrated method troubleshooting capability Knowledge, skills, and expertise in performing chemical experiments that involve the use of liquids, or "wet" chemicals Salary Range: 55-65/hr Requirements 5 years of manufacturing, quality or engineering in the biotech or pharmaceutical industry with a BS/BA Degree in Science/related field Strong understanding of the underlying principles of chemistry, as well as knowledge of laboratory safety and best practices Strong experience with ICH Q2 method qualification/validation requirements, USP, EP, and JP Pharmacopeia Hands-on analytical instrumentation experience is preferred. Knowledge of Good Manufacturing Practices {also cGMP} compliance requirements for Quality Control Laboratories, and experience with a wide range of analytical techniques. Strong verbal and written communication skills What We Offer: Competitive Compensation: Attractive salary and comprehensive benefits package for full-time and part-time employees, including health, dental, vision, and life insurance, a 401(k) plan with employer match, a generous paid time off policy, and additional perks. Compensation is commensurate with professional experience. Career Development: Opportunities for professional growth and advancement within a supportive and innovative environment. Work-Life Balance: Flexible work arrangements and a commitment to maintaining a healthy work-life balance. ELIQUENT Life Sciences is proud to be an
Equal Opportunity Employer , committed to employee diversity.
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QC Method Validation Engineer
to join our team. The role involves validation of quality control instruments, review of turnover packages, and update of instrument operations and maintenance Standard Operating Procedures (SOPs). Validation of quality control instruments including the following: HPLC, GC, UV-Vis, FTIR, Dissolution, TOC analyzers, Microscope, Refrigerated Centrifuge, Microplate Shaker, Vortex Mixer, etc. Review of turnover packages (TOPs) and applicable work instructions Review and update User Requirements Specifications (URS) and generate system design and configuration specifications Review and update instrument operations and maintenance Standard Operating Procedures (SOPs) Complete Equipment Classification(s) & Calibration forms Manage/support vendor instrument IOQ process and develop/execute appropriate PQ protocols Author PQ final reports including trace matrices and data integrity assessments Develop Transfer/Validation/Verification protocols for QC Analytical Methods Develop method SOPs for multiple materials Demonstrated method troubleshooting capability Knowledge, skills, and expertise in performing chemical experiments that involve the use of liquids, or "wet" chemicals Salary Range: 55-65/hr Requirements 5 years of manufacturing, quality or engineering in the biotech or pharmaceutical industry with a BS/BA Degree in Science/related field Strong understanding of the underlying principles of chemistry, as well as knowledge of laboratory safety and best practices Strong experience with ICH Q2 method qualification/validation requirements, USP, EP, and JP Pharmacopeia Hands-on analytical instrumentation experience is preferred. Knowledge of Good Manufacturing Practices {also cGMP} compliance requirements for Quality Control Laboratories, and experience with a wide range of analytical techniques. Strong verbal and written communication skills What We Offer: Competitive Compensation: Attractive salary and comprehensive benefits package for full-time and part-time employees, including health, dental, vision, and life insurance, a 401(k) plan with employer match, a generous paid time off policy, and additional perks. Compensation is commensurate with professional experience. Career Development: Opportunities for professional growth and advancement within a supportive and innovative environment. Work-Life Balance: Flexible work arrangements and a commitment to maintaining a healthy work-life balance. ELIQUENT Life Sciences is proud to be an
Equal Opportunity Employer , committed to employee diversity.
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