CQV Engineer

PSC Biotech•Columbia, MO

6d•Onsite

About The Position

PSC Biotech is seeking an experienced Commissioning, Qualification, and Validation (CQV) Engineer to support capital projects at a medical device manufacturing facility in Columbia, Missouri. This six-month W2 temporary contract may be extended. The role executes CQV activities for new and existing equipment, systems, and facility improvements in a regulated manufacturing environment, supporting multiple projects and independently managing assigned qualification activities. The engineer plans, coordinates, and executes CQV work throughout the project lifecycle; develops, reviews, and executes protocols and related documentation; reviews project documentation against specifications and validation requirements; and documents and helps resolve discrepancies, deviations, and qualification issues. The position works with Engineering, Quality, Manufacturing, and other project stakeholders while maintaining accurate documentation under applicable quality and documentation requirements. Applicants must be legally authorized to work in the United States. Employer-sponsored work authorization is not available, and Corp-to-Corp arrangements are not considered. W2 temporary roles include medical and sick time benefits.

Requirements

Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline.
At least five years of professional CQV experience within a regulated manufacturing environment.
Hands-on experience with commissioning, qualification, and validation activities.
Experience supporting capital projects involving manufacturing equipment, systems, facilities, or utilities.
Strong experience developing, reviewing, and executing CQV protocols and associated documentation.
Ability to independently manage CQV deliverables and work effectively within cross-functional project teams.
Strong technical writing, documentation, organization, and problem-solving skills.
Must be legally authorized to work in the United States; employer-sponsored work authorization is not available.
Corp-to-Corp arrangements are not considered.

Nice To Haves

Experience within the medical device industry or a similarly regulated environment.

Responsibilities

Plan, coordinate, and execute CQV activities supporting capital projects.
Develop, review, and execute CQV documentation and protocols for equipment, systems, and facility-related projects.
Support qualification throughout the project lifecycle, including installation, operational, and performance qualification, as applicable.
Review project documentation to ensure equipment and systems meet defined specifications and validation requirements.
Identify, document, and support resolution of discrepancies, deviations, and qualification-related issues.
Collaborate with Engineering, Quality, Manufacturing, and other cross-functional stakeholders to support project execution.
Maintain accurate and complete CQV documentation in accordance with applicable quality and documentation requirements.
Support multiple capital projects and adapt CQV activities to project scope, priorities, and timelines.
Provide technical CQV expertise and independently manage assigned qualification activities.