Facilities Engineer II
On-siteHouston, Texas, United States
Houston, Texas, United StatesOn-siteFull TimeBachelors DegreeHealthcare TechMedium
Full TimeBachelors DegreeMediumHealthcare Tech
Job Summary
Draft validation documents including plans, user requirements specifications, risk assessments, and IQ/OQ/PQ protocols. Execute test scripts using good documentation practices and create project timelines for asset implementation and requalification. Monitor Quality Management Systems, including CAPAs, deviations, and change controls, to ensure compliance with FDA cGMP and regulatory requirements. Draft SOPs, work instructions, and training materials while supporting cross-functional groups for audits and investigations. Coordinate asset lifecycle activities and investigate equipment issues within GxP operations.
Required Qualifications
- Bachelors degree in Biotechnology, Mechanical, Electrical, Chemical Engineering, or related field
- 5+ years in pharmaceutical or biotech engineering within a GxP regulated manufacturing or laboratory environment
- 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, where permitted by applicable law
Desired Qualifications
- Demonstrated knowledge of FDA and cGMP requirements
- Applied experience in good documentation practices and data integrity principles
- An 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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