Validation Engineer
Validation Engineer
Supports validation and commissioning for equipment, utilities, facilities, and controlled temperature units in a regulated pharmaceutical/biopharmaceutical environment. Requires a bachelor’s in engineering or related science, 2–6 years’ validation experience, and knowledge of cGMP, ICH, and FDA regulations.
Validation Engineer II
Location: 14905 Kirby Drive, Houston, TX 77047
Contract Duration: 6 Months — Potential Extension or Full-Time Conversion
Pay Rate: $50.00–$63.85/hour (W2)
Benefits: Weekly Pay, Medical, Dental, and Vision Insurance
Position Overview
We are seeking a Validation Engineer II to support validation and commissioning activities for equipment, utilities, facilities, and controlled temperature units within a regulated pharmaceutical/biopharmaceutical environment. The ideal candidate will have hands-on experience developing and executing validation protocols, analyzing validation data, and ensuring compliance with cGMP and applicable FDA regulations.
Key Responsibilities
- Develop and execute validation protocols and reports for equipment, utilities, and facilities, including IQ, OQ, and PQ.
- Develop and execute Commissioning, Qualification, and Validation (CQV) deliverables for temperature mapping of Controlled Temperature Units (CTUs).
- Coordinate validation activities with cross-functional teams, including Manufacturing, Quality Assurance, Engineering, and R&D.
- Review and analyze validation data, identify deviations, and recommend appropriate Corrective and Preventive Actions (CAPAs).
- Prepare and present validation summaries, reports, and supporting documentation for internal and external audits.
- Participate in the review and approval of change controls associated with validated systems and equipment.
- Ensure validation activities are conducted in accordance with applicable regulatory requirements, company procedures, and quality standards.
Required Qualifications
- Bachelor’s degree in Engineering (Chemical, Biomedical, Mechanical, or equivalent) or a related scientific discipline.
- 2–6 years of validation experience within the pharmaceutical, biopharmaceutical, or other regulated industry.
- Strong knowledge of cGMP, ICH guidelines, and FDA regulations, including 21 CFR Parts 210, 211, and 820.
- Proven hands-on experience with IQ, OQ, and PQ activities.
- Experience developing, executing, and documenting validation protocols and reports.
- Strong analytical and problem-solving skills, with the ability to evaluate validation data and address deviations.
Preferred Experience
- Hands-on experience with temperature mapping of Controlled Temperature Units (CTUs).
- Familiarity with FDA and cGMP requirements related to equipment and facility validation.
- Experience supporting CQV activities in pharmaceutical or biopharmaceutical manufacturing environments.
- Experience working collaboratively with Manufacturing, QA, Engineering, and R&D teams.
- Strong technical writing and documentation skills.
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