Senior Facilities Engineering Manager
On-siteHouston, Texas, United States
Job Summary
Lead validation and qualification of GMP manufacturing equipment, process utilities, HVAC systems, and cleanrooms, overseeing the IQ, OQ, PQ lifecycle to ensure assets are reliable for production and commercial launch. Develop and manage preventive and predictive maintenance strategies, asset criticality analysis, and equipment lifecycle planning to maximize uptime and reduce unplanned downtime. Support the transition from late-stage clinical to commercial operations while partnering with Quality to manage deviations, lead equipment investigations, execute CAPAs, and support change controls. Mentor engineering teams and manage budgets and KPIs for the Facilities Engineering group. Monday to Friday schedule with on-call support as needed.
Required Qualifications
- Bachelors degree in Mechanical, Electrical, Chemical Engineering, or related field
- 7+ years in pharmaceutical or biotech engineering within a GxP regulated manufacturing or laboratory environment
- 5+ of those years directly leading teams
- Work Authorization: Applicants must be authorized to work in the United States without the need for current or future sponsorship
- Employment is contingent upon successful completion of a background check, reference checks and pre-employment drug screening
Desired Qualifications
- Strong knowledge of FDA and cGMP requirements
- Deep experience with IQ/OQ/PQ with exposure to CSV interfaces
- Expertise in cleanrooms and critical utilities
- Experience supporting commercial biologics or cell therapy manufacturing
- Familiarity with CMMS, BMS/EMS, digital maintenance systems
- PMP or similar certification is advantageous
- Demonstrated understanding of 21 CFR Part 11, 21 CFR Part 210, 21 CFR Part 211, EU Annex 1, and USP
- Experience in writing and reviewing Deviations and CAPAs, investigations resulting from OOS/OOT, environmental excursions, lab investigations leading to Change Controls for QMS
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