Job Description: This position is responsible for maintaining and improving and/or upgrading process support equipment for biopharmaceutical manufacturing and aseptic filling operations. The role supports operations in ensuring use-ready and compliant equipment, including advanced troubleshooting, preventive maintenance, upgrade, and authoring, review, update, and completion of CMMS and GMP-related documentation.
Essential Duties and Responsibilities:- Troubleshoot complex problems, complete emergency repairs, and guide staff in implementing repairs.
- Maintain equipment in use-ready, compliant state. Major equipment includes lyophilizer, PLC, SCADA, HMI, clean steam, WFI, Autoclaves, Depy Ovens and others.
- Monitor, respond to, and correct issues generating equipment alarms.
- Provide recommendation for, and implement upgrades and improvements.
- Author, review, and update maintenance procedures and forms.
- Complete CMMS entries and required training activities.
- Travel between facilities to support all functional areas.
- 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.
Qualifications: - High school diploma or equivalent experience required.
- Minimum of 8 years of relevant experience required.
- Minimum of 4 years of cGMP experience required.
- Advanced mechanical and electrical troubleshooting skills.
- Ability to read and understand equipment schematics.
- General understanding of support equipment.
- Experience with components such as PLCs, VFDs, and servos.
- Experience with safety circuits.
- Experience with aseptic filling is preferred but not required.
- Ability to work in a group, and independently.
- 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 hiring rate for this position is $40.92 - 46.04/hour 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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