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.
- Regular and reliable attendance on a full-time basis [or in accordance with posted schedule].
- Responsible for exhibiting 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.
- Embodies PCI Pharma Service's cultural values and aligns daily actions with department goals and company culture.
- 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.
The base salary hiring range for this position is $106,800 - $120,150 plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k).
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