
Posted 9 days ago
Senior Reliability Engineer
PCI Pharma Services
Requirements
Bachelor's degree in ChE, EE, IE, ME, CS or similar, 7-10+ years engineering experience, 4+ years cGMP experience, Knowledge of automation standards (GAMP), Experience with Allen Bradley, Siemens, Wonderware, iFix, or PI, Proficiency in Microsoft Office
Skills
GMPAllen BradleySiemensAutomation
About the role
Responsibilities
- Maintain and troubleshoot manufacturing and utility equipment, including automated control systems and Building Management Systems.
- Provide technical leadership in plant and equipment reliability within a cGMP environment.
- Author and update critical technical documentation such as URS, FDS, SAT, I/O/PQ, and SOPs.
- Manage system changes through formal change management procedures, including data integrity assessments and CAPAs.
- Evaluate existing systems for continuous improvement and research new technologies for implementation.
- Act as a technical and professional mentor for junior engineering colleagues.
- Perform in-depth technical reviews of GMP documentation and close out audit observations.
Requirements
- Bachelor's degree in Chemical Engineering, Electrical Engineering, Industrial Engineering, Mechanical Engineering, Computer Science, or a similar discipline.
- 7-10+ years of relevant engineering experience.
- Minimum of 4 years of experience working within a cGMP environment.
- Strong knowledge of automation standards, including GAMP.
- Hands-on experience with control platforms such as Allen Bradley, Siemens, Wonderware, iFix, or PI.
- High proficiency in Microsoft Office applications.
- Excellent critical thinking, attention to detail, and communication skills.
Benefits
- Competitive base salary with eligibility for an annual performance bonus.
- Comprehensive health insurance coverage, including dental and vision.
- Paid time off.
- Flexible spending account.
- 401(k) retirement plan.
About the Company
PCI Pharma Services is a global provider of pharmaceutical services, acting as a bridge between life-changing therapies and the patients who need them. We focus on quality, operational excellence, and providing an industry-leading experience for our people and customers through purposeful work and intentional learning.
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PCI Pharma Services · San Diego
