Pharmaceutical Validation Engineer

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to clients worldwide. Our client is a leading biotechnology company combining technological insight with world-class manufacturing, scientific expertise, and process excellence to help deliver new and innovative medicines for a wide range of diseases. The company specializes in pharmaceutical ingredients, bioscience, biopharmaceuticals, custom manufacturing, biotechnology, life science ingredients, nutrition, microbial control, agriculture, materials science, personal care, and cell and gene therapy.

About the role

The Pharmaceutical Validation Engineer is responsible for developing and executing validation and CQV activities for equipment, utilities, facilities, and Controlled Temperature Units. The role supports cross-functional teams in ensuring compliance with cGMP, FDA, and ICH regulatory requirements within a pharmaceutical or biopharmaceutical manufacturing environment.

Responsibilities

• Develop and execute validation protocols and reports for equipment, utilities, and facilities, including IQ, OQ, and PQ.
• Develop and execute CQV deliverables for Temperature Mapping of Controlled Temperature Units.
• Coordinate validation activities with Manufacturing, Quality Assurance, Engineering, and R&D teams.
• Analyze validation data, identify deviations, and recommend Corrective and Preventive Actions (CAPAs).
• Prepare and present validation summaries and reports for internal and external audits.
• Participate in the review and approval of change controls related to validated systems.

Requirements

• Bachelor’s degree in Engineering (Chemical, Biomedical, Mechanical, or equivalent) or a related scientific discipline.
• 2-6 years of validation experience in the pharmaceutical or biopharmaceutical industry.
• Strong knowledge of cGMP, ICH guidelines, FDA regulations (21 CFR Parts 210, 211, and 820), and other applicable regulatory requirements.
• Hands-on experience with Temperature Mapping for Controlled Temperature Units.
• Proven experience in Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Familiarity with FDA and cGMP compliance standards.
• Strong analytical, documentation, and cross-functional collaboration skills.

Pay

$35 to $39 per hour

Schedule

• 6-month temporary assignment
• Onsite in Houston, TX (77047)
• Monday to Friday, 1st shift