Overview
We are seeking an experienced CQV Engineer to support a major pharmaceutical site expansion project in the greater Indianapolis area. This is a long-term, onsite contract opportunity within a dynamic cGMP manufacturing environment, requiring hands-on execution of commissioning, qualification, and validation (CQV) activities.
The ideal candidate will bring strong technical expertise in equipment and system validation, along with experience using digital validation platforms such as KNEAT. This role plays a critical part in ensuring compliance, quality, and inspection readiness during facility expansion and startup activities.
Key Responsibilities
- Execute Commissioning, Qualification, and Validation (CQV) activities for manufacturing equipment, utilities, and systems.
- Perform and document Installation Qualification (IQ) and Operational Qualification (OQ) protocols in a cGMP environment.
- Author, review, route, execute, and approve validation documentation using KNEAT or similar digital validation systems.
- Conduct equipment and system testing, ensuring accurate, real-time electronic documentation of results.
- Develop test scripts, acceptance criteria, and traceability matrices aligned with project and regulatory requirements.
- Identify, document, and resolve deviations using electronic quality management systems.
- Collaborate cross-functionally with engineering, quality, and manufacturing teams to ensure timely execution of validation activities.
- Maintain inspection-ready validation packages in compliance with FDA and global regulatory standards.
- Support project timelines, milestones, and deliverables for site expansion initiatives.
Required Qualifications & Experience
- Bachelor’s degree in Engineering, Life Sciences, or a related technical field.
- Proven hands-on CQV execution experience in a GMP-regulated manufacturing environment.
- Strong experience executing IQ/OQ protocols (PQ experience is a plus).
- Working knowledge of KNEAT or other digital validation lifecycle management tools.
- Experience with documentation-heavy validation projects and maintaining compliance standards.
- Solid understanding of cGMP regulations, FDA guidelines, and validation best practices.
- Strong attention to detail, documentation accuracy, and data integrity principles.
- Ability to work independently in a fast-paced, onsite project environment.
Preferred Qualifications (Nice to Have)
- Experience supporting site expansion, greenfield, or brownfield projects.
- Exposure to FAT/SAT coordination, equipment startup, and commissioning activities.
- Background in pharmaceutical, biotechnology, or CDMO manufacturing environments.
- Familiarity with additional validation or quality systems (e.g., TrackWise, Veeva, etc.).
