Senior Process & CQV Engineer
Position Summary
We're looking for a Senior Process Engineer to lead validation efforts for complex manufacturing operations. This role focuses on creating and executing process qualification strategies, ensuring compliance, and driving successful outcomes across multiple projects. The ideal candidate will have deep expertise in process validation, strong leadership skills, and experience managing client-facing initiatives.
You'll work on advanced biopharma and cell therapy projects, collaborating with industry leaders to deliver innovative solutions for clinical and commercial manufacturing.
Key Responsibilities
- Develop and implement process validation protocols for qualification activities.
- Coordinate sampling, testing, and data collection with internal teams and external labs.
- Prepare detailed reports and final documentation for review and approval.
- Manage multiple projects simultaneously, acting as the primary client contact.
- Lead cross-functional teams including Manufacturing, Quality, Regulatory, and Process Sciences.
- Identify opportunities for business growth and propose technical solutions.
- Provide on-site oversight for protocol execution when required.
- Utilize advanced project management tools for scheduling and tracking.
Qualifications
Required:
- Proven ability to lead projects independently and manage cross-functional teams.
- Experience in clinical and commercial manufacturing within Quality or Process Sciences.
- Strong understanding of validation requirements for:
- Small molecule synthesis
- Biologics (proteins, monoclonal antibodies)
- Cell therapy and regenerative medicine
- Sterile drug product fill/finish
Compensation
Salary range: $150K-$200K, plus bonus opportunities and comprehensive benefits.
Benefits & Culture
We offer:
- Flexible work arrangements.
- Competitive compensation and bonus plan.
- Comprehensive health coverage (medical, dental, vision).
- Paid holidays, PTO, and parental leave.
- Professional development and certification support.
- 401(k) with immediate vesting.
- A collaborative, growth-focused culture with advancement opportunities.
FAQs
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