Job Title: General Mechanic

Work Location: Bucks County, Pennsylvania

Summary:

Perform mechanical maintenance, repairs, and equipment changeovers to ensure the reliable operation of manufacturing and facility equipment supporting pharmaceutical production. Execute preventive and corrective maintenance activities to minimize downtime, maintain equipment integrity, and support production schedules. Troubleshoot mechanical issues, identify root causes, and implement effective corrective actions in compliance with cGMP and safety requirements. Support equipment installations, inspections, and system improvements to enhance operational efficiency and equipment performance.

Responsibilities:

• Set up, adjust, operate, and mechanically support manufacturing and facility equipment to ensure proper and efficient operation.
• Perform equipment changeovers, including product, size, and format changes, in accordance with approved procedures and production requirements.
• Conduct preventive maintenance activities per established schedules and maintenance plans to maintain equipment reliability.
• Troubleshoot, diagnose, and repair mechanical issues, applying sound technical judgment to determine root cause and corrective actions.
• Support equipment installations, inspections, and modifications in coordination with Engineering, Production, and Quality.
• Execute assigned maintenance tasks in support of equipment qualification, validation, and requalification activities as required.
• Accurately complete maintenance documentation, including equipment logs, work orders, and CMMS entries, in compliance with ALCOA+ principles.
• Ensure equipment is properly cleaned, assembled, and maintained in accordance with approved SOPs.
• Communicate effectively with Maintenance leadership, Production, and Quality Assurance regarding equipment status, issues, and corrective actions.
• Identify, document, and promptly report equipment-related quality concerns, deviations, or safety hazards.
• Maintain continuous compliance with cGMPs, FDA regulations, safety policies, and company procedures.
• Perform other duties as assigned in support of facility and operational needs.

Qualifications:

• High School Diploma or GED required.
• Technical or vocational training in mechanical maintenance, industrial equipment, or a related field preferred.
• Minimum of 2–5 years of hands-on mechanical maintenance experience in a regulated manufacturing, pharmaceutical, biotech, or industrial environment.
• Experience supporting production or packaging equipment in a cGMP-regulated facility strongly preferred.
• Strong mechanical aptitude with the ability to set up, adjust, maintain, and repair manufacturing and facility equipment.
• Demonstrated experience troubleshooting mechanical systems and resolving equipment failures efficiently.
• Ability to read, interpret, and follow SOPs, technical manuals, maintenance procedures, and batch-related documentation.
• Proficiency in completing maintenance documentation accurately and in compliance with cGMP and data integrity requirements.
• Strong organizational skills with the ability to manage multiple tasks and priorities.
• Ability to safely use tools, equipment, and personal protective equipment appropriate to the role.
• Willingness and ability to obtain and maintain gowning qualification as required for controlled environments.

Published Category: Manufacturing & Technical Operations