CQV Engineer

PSC Biotech•Columbia, MO

4d•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 W-2 temporary contract may be extended. The engineer will execute CQV activities for new and existing equipment, systems, and facility improvements in a regulated manufacturing environment, supporting multiple projects and managing assigned qualification activities independently. Applicants must be legally authorized to work in the United States; employer-sponsored work authorization and Corp-to-Corp arrangements are not available. PSC Biotech provides services to the life sciences industry and describes a global, multicultural team with an emphasis on employee coaching, development, and career growth. W-2 temporary roles include medical and sick time benefits. PSC Biotech is an equal opportunity employer.

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 unavailable.
Corp-to-Corp arrangements will not be considered.

Nice To Haves

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

Responsibilities

Plan, coordinate, and execute commissioning, qualification, and validation activities supporting capital projects.
Develop, review, and execute CQV documentation and protocols for equipment, systems, and facility-related projects.
Support qualification activities throughout the project lifecycle, including installation, operational, and performance qualification, as applicable.
Review project documentation to ensure systems and equipment 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.