Jobs · Engineering · California

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.

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