Engineering Maintenance Lead

Role Summary

Engineering Maintenance Lead. We are looking for an Engineering Maintenance Lead to join the process engineering team supporting our new R&D Steriles pilot plant facility in Marietta, PA. This role will be responsible for developing and managing the process equipment maintenance program, supporting process design, equipment procurement, commissioning, and qualification, and coordinating with key stakeholders such as operations, quality assurance, EHS, and validation.

Responsibilities

• Participate and lead design meetings with equipment vendors
• Develop and manage the maintenance program for R&D Process Engineering
• Develop and manage the R&D (Research & Development) Process Engineering spare parts program
• Review design documents, specifications, P&IDs, and protocols from vendors
• Participate in, support, and/or execute FATs (Factory Acceptance Test), SATs(Site Acceptance Test) commissioning's, and qualification activities
• Generate safety assessments and procedures
• Lock-out-tag-out Hazardous Energy Control Procedures, Safety Risk Assessments, Permit-to-Work
• Coordinate planned and unplanned maintenance activities with stakeholders operations, quality, sterility assurance, EHS, tech services, etc.
• Troubleshoot equipment failures and provide guidance/direction on remediation options
• Perform root cause analyses for systemic production issues related to process equipment

Qualifications

• Required: 5+ years maintenance or engineering experience for process equipment
• Required: Pharmaceutical/Vaccines experience
• Required: 1+ years of people management experience
• Required: Electrical and mechanical experience
• Required: Experience troubleshooting equipment failures, Reading P&IDs and electrical drawings
• Preferred: Experience supporting Aseptic Formulation/Compounding and Filling (sterile product) manufacturing
• Preferred: Small-scale Project Management experience (ex. new equipment/process introduction and/or equipment/process modification)
• Preferred: Process Equipment maintenance experience
• Preferred: Familiarity with preventative and corrective maintenance programs
• Preferred: Spare parts management
• Preferred: Filler, lyophilizer/freeze-dryer, capper, autoclave, washer, COP/SOP stations, isolators
• Preferred: Coordination and management of vendors such as original equipment manufacturers (OEMs)
• Preferred: Safety experience issuing PTWs (Permit to Work), writing and executing LOTO (Lock-out-tag-out) procedures and authoring equipment safety risk assessments

Additional Requirements

• Employees need to be onsite for 4-5 days in a week.