Eliquent Life Sciences
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. For more information, please visit our website at eliquent.com.
We are seeking an experienced Quality professional to serve in a consultant role reviewing CQV documentation in support of a new sterile fill/finish production line at one of our anchor accounts. The ideal candidate will bring strong knowledge of cGMP principles, validation lifecycle requirements, and documentation standards within regulated environments. This role will not involve authoring or executing validation protocols, but rather reviewing documentation for compliance, completeness, and alignment with applicable regulatory and internal standards.
Key Responsibilities:
Review Commissioning, Qualification, and Validation (CQV) documentation (e.g., protocols, summary reports, risk assessments) for equipment, facilities, utilities, cleaning, and computerized systems associated with a sterile fill/finish production line. Ensure reviewed documentation complies with applicable regulatory expectations (e.g., FDA, EU Annex 15, ICH Q8-Q10) and internal procedures. Provide feedback and recommendations to project teams on documentation content, structure, and alignment with industry best practices. Collaborate cross-functionally with client Engineering, Validation, Quality, and Project Management teams to advise on quality expectations and CQV documentation readiness. Utilize client systems including Veeva Vault, TrackWise, and Maximo to support document review, change control, and issue tracking activities. Support resolution of quality comments or issues related to validation documentation through advisory input and collaborative problem-solving Requirements
Bachelor's degree in Engineering, Life Sciences, or a related field. 8+ years of experience in validation or quality roles in the pharmaceutical or biotechnology industry. Strong knowledge of validation documentation lifecycle, cGMPs, and regulatory guidance related to equipment, facilities, and computerized systems. Experience reviewing CQV documentation in sterile or aseptic manufacturing environments. Familiarity with Quality Management Systems such as Veeva Vault, TrackWise, and Maximo. Excellent attention to detail, written communication skills, and ability to provide constructive quality input Preferred Qualifications:
Prior consulting or advisory experience. Experience supporting large-scale capital projects or greenfield facility startups. Understanding of barrier technology, aseptic process validation, or automated fill/finish equipment. Benefits
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.
We are seeking an experienced Quality professional to serve in a consultant role reviewing CQV documentation in support of a new sterile fill/finish production line at one of our anchor accounts. The ideal candidate will bring strong knowledge of cGMP principles, validation lifecycle requirements, and documentation standards within regulated environments. This role will not involve authoring or executing validation protocols, but rather reviewing documentation for compliance, completeness, and alignment with applicable regulatory and internal standards.
Key Responsibilities:
Review Commissioning, Qualification, and Validation (CQV) documentation (e.g., protocols, summary reports, risk assessments) for equipment, facilities, utilities, cleaning, and computerized systems associated with a sterile fill/finish production line. Ensure reviewed documentation complies with applicable regulatory expectations (e.g., FDA, EU Annex 15, ICH Q8-Q10) and internal procedures. Provide feedback and recommendations to project teams on documentation content, structure, and alignment with industry best practices. Collaborate cross-functionally with client Engineering, Validation, Quality, and Project Management teams to advise on quality expectations and CQV documentation readiness. Utilize client systems including Veeva Vault, TrackWise, and Maximo to support document review, change control, and issue tracking activities. Support resolution of quality comments or issues related to validation documentation through advisory input and collaborative problem-solving Requirements
Bachelor's degree in Engineering, Life Sciences, or a related field. 8+ years of experience in validation or quality roles in the pharmaceutical or biotechnology industry. Strong knowledge of validation documentation lifecycle, cGMPs, and regulatory guidance related to equipment, facilities, and computerized systems. Experience reviewing CQV documentation in sterile or aseptic manufacturing environments. Familiarity with Quality Management Systems such as Veeva Vault, TrackWise, and Maximo. Excellent attention to detail, written communication skills, and ability to provide constructive quality input Preferred Qualifications:
Prior consulting or advisory experience. Experience supporting large-scale capital projects or greenfield facility startups. Understanding of barrier technology, aseptic process validation, or automated fill/finish equipment. Benefits
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.