Senior Facilities Engineer
PCI Pharma Services · San Diego, CA · 1 wk ago
EngineeringFull-time
Essential Duties And Responsibilities
- Maintain and troubleshoot manufacturing and utility equipment.
- Update manufacturing systems.
- Provide input and author URS, FDS, SAT, I/O/PQ, and SOP documents.
- Document changes to systems per change management procedures.
- Research new technologies and make recommendations.
- Advanced knowledge of plant and equipment reliability.
- Travel between facilities to support all functional areas.
- Maintain and troubleshoot automated control systems related to process equipment as well as the Building Management System (Siemens: Insight and Desigo).
- Evaluate existing systems for continuous improvement.
- Provide in-depth technical review of all documents and complete GMP documentation including change controls, data integrity assessments, deviations and CAPAs, and the closing of audit observations.
- Act as a technical and professional mentor for junior colleagues.
- Maintain regular and reliable attendance on a full-time basis [or in accordance with posted schedule].
- Exhibit professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
- Foster a safe and environmentally sustainable workplace by following all PCI EHS policies and procedures.
Qualifications
- Bachelor's degree in ChE, EE, IE, ME, CS, or similar discipline or equivalent experience required.
- Minimum of 7-10+ years of relevant engineering experience including a minimum of 4 years cGMP experience.
- Understanding of plant and equipment reliability preferred.
- Well-developed understanding of automation standards (including GAMP).
- Well-developed understanding of control platforms from multiple vendors (Allen Bradley, Siemens, Wonderware, iFix, PI).
- Extremely strong working knowledge of GMP, aseptic techniques, and laboratory compliance.
- Highly proficient in Microsoft Office applications.
- Excellent attention to detail, critical thinking, and communication skills.
- Able to work autonomously, drive results, and collaborate in a cross-functional environment.