Job Title: CQV Engineer (Process Equipment – Execution Focus)
Location: Devens, MA (Onsite)
Duration: 3–4 Months
Schedule: First Shift (7:00 AM – 2:00 PM, Monday–Friday;)
Position Overview
We are seeking two experienced CQV Engineers to support a large-scale cell culture facility expansion within an existing GMP environment. This role focuses strictly on execution of pre-written validation protocols in ValGenesis and hands-on qualification of process equipment.
The resources will support equipment installation, system verification, IQ/OQ execution, and post-qualification activities for newly installed equipment arriving in mid-June. This is a fast-paced, timeline-driven project requiring strong independent execution skills and experience in biologics manufacturing environments.
Key Responsibilities
CQV Execution (Primary Focus)
- Execute Installation Qualification (IQ) and Operational Qualification (OQ) protocols.
- Perform detailed walkdowns of systems, verifying field installation against approved drawings and specifications.
- Confirm equipment configuration, utilities, and process flow alignment with functional design.
- Verify maintenance systems are active and properly integrated.
- Execute wet testing and operational checks.
- Support SIP/CIP cycle verification and development in coordination with Manufacturing Engineering.
- Perform steam-in-place temperature mapping activities.
- Conduct BI (biological indicator) handling, training, and retrieval activities.
- Review process data and coordinate with QC laboratories for report alignment.
- Generate execution records and complete all documentation in ValGenesis (e-validation platform).
Equipment Focus
- Large-scale cell culture systems (up to 20kL bioreactors)
- Downstream equipment including:
- Harvest clarification systems
- Viral filtration systems
- Ultrafiltration systems
- Buffer transfer systems
- Tank farms
- Chromatography systems
- Steam-based clean-in-place systems
Documentation & Compliance
- Ensure all execution activities follow GDP standards.
- Maintain strict adherence to GMP and validation best practices.
- Support compressed project timelines with multi-shift coordination.
- Collaborate cross-functionally with Engineering, Manufacturing, and Quality teams to ensure successful system turnover.
Required Qualifications
- 4–7 years of CQV experience in pharmaceutical or biologics manufacturing.
- Strong hands-on experience with process equipment qualification (IQ/OQ).
- Proven experience in downstream biologics equipment validation.
- Experience working in large-scale cell culture environments.
- Familiarity with steam systems, SIP/CIP processes, and flow path verification.
- Experience executing protocols in ValGenesis or similar e-validation platforms.
- Strong understanding of GDP and GMP documentation practices.
- Ability to work independently while maintaining alignment within a team structure.
- Comfortable working onsite in a fast-paced, time-sensitive environment.
Preferred Experience
- Experience with compressed validation schedules.
- Exposure to facility expansions within existing GMP environments.
- Strong technical troubleshooting skills during equipment installation and commissioning.