Computer System Validation Engineer

One of our Global Biopharmaceutical clients is seeking a Validation Engineer to consult on a MES Upgrade project. This person will be responsible for validating code in their MES system as well as DeltaV. This role requires an individual who is both technically proficient and detail-oriented, capable of developing and executing validation protocols for complex manufacturing execution systems (MES) and DeltaV control systems. You will collaborate with cross-functional teams to support our mission of maintaining excellence in quality and compliance.

Duties Include:

Serve as a subject matter expert on MES (AspenTech) and DeltaV systems within the biopharmaceutical environment.

Write, review, and execute validation protocols including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for systems in line with GMP requirements.

Prepare and maintain comprehensive validation documentation, risk assessments, and change control records.

Perform detailed testing of system functionalities, data integrity, and regulatory compliance

Ensure that validation activities are compliant with internal policies and external regulations.

Compensation:

$45-65/hr

Exact compensation may vary based on several factors, including skills, experience, and education.

Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.