Aseptic Production Technician

Sanofi • Swiftwater, PA

1d • Onsite

About The Position

The Aseptic Production Technician performs manufacturing activities in accordance with production needs, effective procedures, and cGMP requirements. The role supports safe and reliable production by preparing materials and processing areas, completing sampling and production documentation, managing inventory records, and identifying operational issues for the leadership team. Technicians work with Senior Technicians and Managers, prepare areas for incoming shifts, and may serve as processing-room leads or develop expertise in assigned areas.

The position includes maintaining and preparing process areas, laboratories, and equipment before and after production runs; completing picklists, move tickets, work orders, and reagent orders, including entries in SAP; and helping maintain inventory. The technician also contributes to documentation and continuous improvement, including recommendations and supervised edits to batch records, SOPs, and work instructions. Other duties include supporting investigations, CAPAs, change controls, projects, and training, as assigned.

The role emphasizes safety and product quality. The technician follows safety procedures, reports hazards and incidents, participates in safety meetings and walkthroughs, and contributes ideas for corrective and preventive actions. The technician works to understand cGMP and applicable regulations, supports inspection readiness and deviation investigations, performs root-cause analysis with the leadership team, and completes quality records accurately and promptly. The role also involves team communication, cross-functional collaboration, developmental classes, cross-training, and training or orienting new team members as assigned.

Requirements

• High school diploma or equivalent and at least 1 year of cGMP, pharmaceutical, or other manufacturing experience; alternatively, an associate degree and at least 6 months of such experience; or a bachelor's degree with or without such experience.
• Good mechanical skills and basic mechanical aptitude.
• Computer skills and ability to use relevant systems.
• Attention to detail, comprehension and retention skills, troubleshooting ability, and manual dexterity.
• Proficiency in at least three areas of operations or the product line.
• Proficiency in at least one of the following: utility sampling, equipment preparation, or tank movement; alternatively, qualification as a trainer in vial wash or debag and SAP.
• Knowledge of and access to applicable systems: SAP, Master, SCADA, RT Reports, and Labware; alternatively, SAP and HMI.

Nice To Haves

• Prior or related cGMP or pharmaceutical experience is recommended.
• Cross-training in additional areas.

Responsibilities

• Perform production activities in accordance with volume fluctuations, business needs, and effective procedures.
• Ensure required materials are available before production needs them.
• Complete required sampling and associated documentation.
• Complete picklists and move tickets accurately and promptly to maintain accurate inventory; enter information in SAP and complete work orders and reagent orders as needed.
• Participate in inventory management, including SAP activities, cycle counting, and ordering.
• Identify production issues and communicate them to the leadership team.
• Prepare assigned areas for incoming shifts.
• Complete tasks and associated documentation in accordance with cGMP requirements.
• Work with Senior Technicians and Managers to support smooth operations; serve as a processing-room lead when needed.
• Complete assigned developmental classes and work toward training in all assigned modules.
• Train and orient new team members as assigned.
• Follow safety procedures, participate in monthly safety meetings and safety walkthroughs, report safety issues and incidents, and contribute ideas for corrective and preventive actions.
• Follow procedures that support production of safe and efficacious products; identify deficiencies and suggest improvements.
• Participate in deviation investigations and implementation plans as appropriate, and assist with root-cause analysis.
• Complete quality documentation, including batch production records and logbooks, accurately and on time.
• Maintain awareness of CFR requirements and FDA audit expectations and support inspection readiness.
• Participate in team meetings, communicate ideas and concerns, and contribute to cross-functional teams and projects.
• Prepare and maintain process areas, laboratories, and equipment before and after production runs.
• Recommend changes to batch production records, SOPs, and work instructions; write and edit documents under supervision.
• Seek cross-training in other areas when possible.
• Assist with incident investigations, CAPAs, change controls, and projects with higher technician levels and Principal Investigators.
• Perform other duties as assigned.

Benefits

• Health and wellbeing benefits, including healthcare, prevention, and wellness programs.
• At least 14 weeks of gender-neutral parental leave.
• Potential eligibility to participate in company employee benefit programs.
• Rewards package recognizing employee contributions.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED