Senior GMP Production Technician – Lead & Compliance

Sanofi; Swiftwater (Monroe County); On-site; USD 70,000 - 90,000; Full time

Job summary

Sanofi is seeking a Senior Production Technician to oversee manufacturing processes in our Swiftwater, PA facility.

The role emphasizes leadership development, strict cGMP compliance, and timely signoffs in SAP, with a focus on safety and quality: Responsibilities include maintaining equipment, training staff, managing documentation in real-time, and supporting CAPA, CCR, and change controls to ensure continuous operation and adherence to FDA regulations.

Qualifications

• HS or GED with 3+ years in cGMP or pharmaceutical experience.
• Associates degree with 2+ years in cGMP or pharmaceutical experience.
• Bachelor's degree with 1+ year in cGMP or pharmaceutical experience.
• Strong mechanical, computer, and detail-oriented abilities.
• Proficiency in at least one operation area or product line.
• Qualified trainer in one or more areas.
• Access to systems (SFD, PI, Metasys, Lab Watch) in applicable buildings and processes.
• Experience with cGMP and FDA regulations.

Responsibilities

• Ensuring that processes are compliant with FDA regulations.
• Maintain and repair equipment and monitor software and hardware issues.
• Train and guide personnel in procedures and SAP signoffs.
• Maintains qualified trainer status.
• Identifying and preventing deviations and assisting in investigation and root cause analysis.
• Ensures operational areas are staffed adequately and breaks are managed.
• Accountable for completion of operations including Metasys and Lab watch, data entry and documentation.
• Acts as liaison for Production and Lead Technicians to dictate support.
• Work with Lead Technicians and managers to ensure continuous operation.
• Help with deviation investigations and CAPA, CCRs, and other projects.
• Ensure that Batch Production Records and logbooks are completed accurately and on time.
• Documentation completed accurately and in real-time for compliance and quality control.
• Prepare areas for next shift to maintain smooth operations and efficiency.
• Use material efficiently to reduce waste.
• Share improvement ideas and provide solutions.
• Proactively identify and solve production issues.
• Uphold HSEEn standards and safety procedures.
• Report safety concerns and incidents promptly.
• Participate in safety meetings and improvement initiatives.
• Maintain a clean, organized, and safe work environment.
• Support continuous improvement actions.
• Follow procedures to ensure safe and efficacious production.
• All other duties as assigned.

Skills

Mechanical skills

Computer skills

Detail oriented

Troubleshooting

Trainer capable

Systems access

Education

HS or GED

Associate degree

Bachelor's degree

Tools

SAP

Job description

Sanofi is seeking a Senior Production Technician to oversee manufacturing processes in our Swiftwater, PA facility.

The role emphasizes leadership development, strict cGMP compliance, and timely signoffs in SAP, with a focus on safety and quality: Responsibilities include maintaining equipment, training staff, managing documentation in real-time, and supporting CAPA, CCR, and change controls to ensure continuous operation and adherence to FDA regulations.