Validation Engineer (CQV)

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.