Job Description

Company Overview:

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 CQV and Process Engineering Consultant to support commissioning, qualification, and validation (CQV) efforts and provide technical leadership in drug product and aseptic fill-finish operations for a growing biotech client. This consulting role will contribute to facility start-up, tech transfer, and regulatory readiness activities for sterile biologics manufacturing, including mAbs, gene therapies, and other advanced modalities. 

The ideal consultant brings deep domain expertise, strong execution skills, and a collaborative mindset suited to fast-paced biotech environments. 

Key Responsibilities: 

CQV Support: 

• Lead or support preparation and execution of CQV deliverables (URS, DQ, FAT/SAT, IQ, OQ, PQ) for drug product equipment and systems including: 

• Isolators/RABS 

• Aseptic filling lines (vials, syringes, cartridges) 

• Lyophilizers 

• Autoclaves, SIP/CIP systems 

• Cleanroom HVAC and clean utility systems (WFI, Clean Steam, Nitrogen) 

• Develop and apply risk-based CQV strategies (per ASTM E2500, ISPE Baseline Guides). 

• Review vendor documentation and support equipment start-up, troubleshooting, and deviation resolution. 

• Ensure compliance with client-specific and regulatory (FDA/EMA) validation standards. 

Process Engineering Expertise: 

• Provide hands-on technical support for sterile fill-finish operations, including drug product formulation, filtration, aseptic transfer, filling, and visual inspection. 

• Assist with process tech transfer from R&D or CMOs to internal manufacturing, including process fit/gap analysis and scale-up readiness. 

• Participate in media fills, cleaning validation, and environmental monitoring strategy review. 

• Contribute to PPQ strategy and execution planning. 

Requirements

Qualifications: 

• Bachelor’s or Master’s degree in Chemical, Mechanical, or Bioprocess Engineering, or related field. 

• 5+ years of experience in CQV and/or process engineering for sterile drug product in biotech or biopharma settings. 

• Demonstrated expertise with isolator systems, lyophilizers, automated filling equipment, and single-use technologies. 

• In-depth knowledge of GMPs, Annex 1, and phase-appropriate validation approaches for biotech drug products. 

• Strong documentation, project coordination, and cross-functional communication skills. 

Preferred Attributes: 

• Able to work independently with minimal supervision while integrating into client teams. 

• Flexible and adaptable to changing project scopes, priorities, and timelines. 

• Familiarity with electronic validation systems (e.g., Veeva, Kneat) is a plus. 

Benefits

• 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.

Job Tags

Similar Jobs