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Validation Engineer

Non-Headquarters

Valpro has several available opportunities supporting our world-class client sites or partner organizations.  Whether you are an independent consultant or a potential employee looking for your next project, learn more about what we have to offer. View our open positions below.

CSV Engineer - Life Sciences Manufacturing

Role Overview

We are seeking a highly skilled and detail-oriented CSV (Computer System Validation) Engineer to support laboratory and freezer equipment in a dynamic life sciences manufacturing environment. This critical role is part of a larger commissioning and qualification project for a new life sciences manufacturing facility. The CSV Engineer will play a central role in ensuring the validation and compliance of equipment and systems within microbiology labs, MSAT labs, bioassay support areas, lab freezers, sample management refrigerators, and cold rooms.

Responsibilities

Validation and Compliance

  • Perform validation activities for laboratory and freezer equipment, including the creation and execution of validation protocols (IQ, OQ, PQ).
  • Ensure compliance with regulatory standards such as FDA, EMA, GxP, and other applicable guidelines.
  • Validate computer systems associated with lab and freezer equipment, ensuring proper functionality, accuracy, and data integrity.
  • Collaborate with QA and regulatory teams to ensure validation documentation meets audit and inspection readiness.

Equipment Qualification

  • Support the commissioning and qualification of microbiology labs, MSAT labs, bioassay support areas, lab freezers, sample management refrigerators, and cold rooms.
  • Develop and execute commissioning plans, including equipment testing and verification.
  • Investigate and resolve any issues related to equipment qualification during execution phases.

Project Collaboration

  • Work as part of a multidisciplinary team involved in commissioning and qualification of the new manufacturing facility.
  • Coordinate with other engineers, technicians, and managers on the integration of equipment and systems.
  • Provide technical support and expertise throughout the commissioning and qualification lifecycle.

Documentation and Reporting

  • Create and maintain detailed validation documentation, including risk assessments, protocols, and reports.
  • Ensure traceability and alignment with project timelines and goals.
  • Review and approve technical documentation related to equipment and systems.

Problem Solving and Risk Assessment

  • Conduct risk assessments for lab and freezer equipment to identify and mitigate potential validation issues.
  • Troubleshoot equipment and system problems, providing timely solutions to ensure project continuity.

Qualifications

  • Bachelor’s degree in Engineering, Life Sciences, or a related field.
  • Minimum 3-5 years of experience in Computer System Validation within the life sciences or pharmaceutical industry.
  • Strong understanding of validation processes and regulatory requirements (FDA, EMA, GxP).
  • Experience with laboratory equipment, freezer systems, and cold storage validation is highly preferred.
  • Proficiency in risk assessment methodologies and problem-solving techniques.
  • Excellent documentation and organizational skills with attention to detail.
  • Ability to work collaboratively in a multidisciplinary team environment.
  • Strong communication skills, both written and verbal.

Preferred Skills

  • Experience supporting large commissioning and qualification projects for new facilities.
  • Familiarity with microbiology labs, MSAT labs, bioassay support areas, and cold storage environments.
  • Knowledge of data integrity principles and computerized systems associated with lab and freezer equipment.
  • Certification in validation or regulatory compliance is a plus.

Work Environment

The CSV Engineer will operate primarily within a life sciences manufacturing environment, including laboratory spaces, cold rooms, and freezer areas. The role may require occasional travel to support project activities and inspections. This position demands flexibility, precision, and the ability to adapt to a fast-paced, regulated industry.

Why Join Us?

By joining our team, you will play a pivotal role in shaping the future of life sciences manufacturing. You will contribute to the validation process of cutting-edge equipment, ensuring the safety and compliance of laboratory operations. This is an exciting opportunity to be part of a groundbreaking project while advancing your career in the field of Computer System Validation.

Application Process

We welcome applications from qualified professionals who share our commitment to excellence in the life sciences industry. To apply, please submit your resume detailing your experience and qualifications for the role.

Take this opportunity to be part of an innovative project that is shaping the future of life sciences manufacturing. Your expertise in validation will directly contribute to the success and compliance of this new facility.

Valpro offers flexible career options that includes benefits such as paid time off, paid holidays, medical, 401K match, and other unique incentives.

Candidates must be legally eligible to work in the United States without company sponsorship.  Also, we are not interested in working on a corp-to-corp basis with other companies at this time.

Any third-party unsolicited resume submission(s) will immediately become the property of Valpro. Valpro will not pay any fee to a submitting employment agency, person, or entity unless a signed agreement is established.

Valpro is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to sex, race, color, religion, national origin, age, sexual orientation, gender identity, disability, protected veteran status or any other protected class. We are committed to providing a professional environment free of any discrimination or harassment, and we are proud to be a Drug-Free Workplace.

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