SPO Mechanical Technician

This position is an individual contributor role within the Operations team of the Vaccines integrated process team, focused on the start-up and future routine operation of the pod vaccine manufacturing facility at the West Point, Pa site.

About the role

The Sterile and Packaging Operations Technician is accountable for performing preventative and corrective maintenance support for formulation, primary filling, inspection, and/or packaging equipment. This role also provides shop floor operations and environmental monitoring support, ensuring Environmental Health and Safety and GMP compliance, troubleshooting equipment issues, and maintaining 100% PM compliance.

Responsibilities

• Set up, adjust, repair, and maintain vaccines formulation, primary filling, inspection, and packaging equipment within the pod vaccine manufacturing facility.
• Execute and develop preventative maintenance for vaccine processing and packaging equipment.
• Conduct corrective maintenance and troubleshooting using diagnostic equipment and programmable logic controllers.
• Partner with operators to execute manufacturing operations tasks.
• Use technical information, drawings, diagrams, and schematics to aid in equipment maintenance, troubleshooting, and repairs.
• Disassemble, inspect, repair, and reassemble equipment with new or repaired parts.
• Perform minor and major overhauls to vaccine processing equipment by completely disassembling, repairing, and reassembling to proper operational condition.
• Assemble and perform millwright functions for the receipt and installation of new equipment.
• Perform work in a safe manner, following identified safety procedures (e.g., hazardous work permitting, using applicable safety equipment/PPE).
• Implement maintenance and operations functions in accordance with current Good Manufacturing Practices (cGMPs).
• Complete documentation in batch records and/or computerized maintenance management systems per site procedures.
• Maintain good housekeeping and 5S in assigned work areas.
• Adhere to data integrity standards while performing maintenance and operations duties.
• Ensure work and adjustments are properly documented and aligned with change management procedures.
• Assist in investigations, root cause determination, and Corrective Action and Preventive Action (CAPA) implementation for compliance discrepancies.
• Participate in new equipment installations by interfacing with vendors, recommending spare parts, selecting lubrication, and assisting engineers.
• Monitor equipment performance and improve reliability through problem-solving and continuous improvement.
• Clean and lubricate equipment periodically and perform other maintenance to ensure efficient operation.
• Determine proper equipment settings, clearances, and set-up standard work to minimize delays or discards.
• Recommend continuous improvement, productivity, and capital projects for the IPT Team.
• Assist engineers and equipment vendors in new equipment installation, including qualification documentation.
• Provide technical and GMP guidance to outside contractors working on process equipment.
• Act as liaison to the Utilities maintenance and Calibration teams.
• Maintain a culture of continuous improvement focused on standard work, problem visibility, waste minimization, and process variability reduction.

Requirements

• High School diploma or equivalent and five (5) years of industrial maintenance experience, or a two (2) year technical degree with three (3) years of maintenance experience or equivalent.

Qualifications

Required Experience and Skills

• Demonstrated industrial maintenance, mechanical, and electrical skills.
• Ability to troubleshoot equipment using a systematic approach.
• Ability to read and understand electrical prints, P&IDs, and control loop diagrams.
• Ability to work independently as a team member.
• Ability to gown and work in an aseptic environment.
• Willingness to work irregular hours to support multi-shift operations.

Preferred Experience and Skills

• Maintenance experience within a vaccine, pharmaceutical, or GMP-regulated environment.
• Experience with aseptic filling, qualified inspection processes, pharmaceutical packaging, and serialization/aggregation.
• Working knowledge of regulated environments (e.g., FDA) and cGMPs in the vaccine/pharmaceutical industry.
• Experience with Continuous Improvement, Lean Manufacturing, Problem Solving, and Right First-Time methodologies.
• Basic knowledge of Systems Applications and Products (SAP) / Manufacturing Execution System (MES).
• Working knowledge of machine shop equipment (e.g., lathe, drill press, grinder, milling equipment, welding, power cutting tools).
• Ability to perform or support technical writing for preventive maintenance procedures (PMs) and standard operating procedures (SOPs).
• Demonstrated ability to work autonomously and help organize priorities for other team members.
• Outstanding communication skills across teams and shifts.

Schedule

• 2nd shift (Evening) or 3rd shift (Night).