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Summary
About the Role
About You
- 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.
- 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 including health, dental, vision, and life insurance.
- 401(k) plan with employer match.
- Generous paid time off policy and additional perks.
- Opportunities for professional growth and advancement within a supportive and innovative environment.
- Flexible work arrangements and a commitment to maintaining a healthy work-life balance.
We are expert consultants delivering the answers and solutions that life sciences innovators need to gain and maintain market authorization for their products. Our unprecedented assembly of regulatory leaders, industry experts, and technical specialists collaborate seamlessly to unlock excellence throughout the product lifecycle. We are the convergence of regulatory expertise and technical capabilities across the therapeutic landscape. From thought to finish, concept to commerce, and strategy to execution— ELIQUENT Life Sciences is the singular regulatory resource that clients around the world trust. Together, ELIQUENT redefines regulatory consulting with a full-service approach and comprehensive solutions that bridge the spectrum of regulatory challenges. Learn more at ELIQUENT.com