Validation Engineer (Process/Cleaning/CSV)

IT MINDS L.L.C.

Kalamazoo, MI

Job Title: Validation Engineer Process/Cleaning/CSV

Start Date: November 2, 2026

Duration: 12 Months

Location: Michigan (MI)

Work Arrangement: Fully Onsite

Job Description:

Our client is seeking multiple Validation Engineers to support commissioning, qualification, and validation activities for a new pharmaceutical/biotechnology manufacturing facility.

The consultants will support process validation, cleaning validation, and Computer System Validation (CSV) activities. Responsibilities include developing and executing qualification protocols, supporting Site Acceptance Testing (SAT), and validating process equipment and manufacturing systems.

Equipment may include filtration systems, filters, tanks, pumps, chromatography systems, bioreactors, and other associated process equipment.

Key Responsibilities

Develop and execute IQ/OQ/PQ qualification and validation protocols, as applicable.
Support Site Acceptance Testing (SAT) and equipment startup activities.
Perform process validation, cleaning validation, and Computer System Validation (CSV).
Review technical documentation and verify compliance with approved requirements.
Conduct risk assessments and maintain requirements traceability.
Investigate and resolve deviations, discrepancies, and validation deficiencies.
Prepare and maintain validation documentation in accordance with GMP standards.
Collaborate with engineering, quality, automation, and equipment vendors to ensure successful facility startup.

Required Qualifications

Strong experience in equipment qualification and validation.
Experience in pharmaceutical, biotechnology, or other regulated manufacturing environments.
Knowledge of GMP requirements and validation documentation.
Experience with qualification protocols, IQ/OQ/PQ, and SAT activities.
Ability to review technical documentation, identify gaps, and resolve validation issues.

Preferred Qualifications

Cleaning validation and process validation experience.
Computer System Validation (CSV) experience.
Risk assessments and requirements traceability.
Deviation management and technical documentation review.
Experience supporting new manufacturing facility startup

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Vacancy posted 1 day ago

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