Role Summary
Senior Manufacturing Technician responsible for operating, setting up, changing over, and cleaning packaging equipment in accordance with SOPs, GMPs, and safety procedures within the Northborough Packaging operation. Will document production activities, follow supervisor instructions, perform manual packaging, handle hazardous materials, and maintain equipment and training in a dynamic, team-oriented environment to support packaging of final drug product vials for U.S., European, and international markets.
Responsibilities
- The candidate will operate, set-up, changeover and clean various automated and manual packaging equipment in strict accordance with SOP’s, Good Manufacturing Practices and Safety policies/procedures.
- Document production activities in batch records, log sheets, attachments and/or electronic Batch Records.
- Follow operational procedures and both written and verbal instructions from the supervisor.
- Perform manual packaging on an assembly line.
- Ability to lift up to 35 lbs. and move heavy objects (e.g., product vial cages, pallets of packaging materials).
- Ability to stand for 3 hours while operating packaging equipment.
- Identify and communicate process deviations to the supervisor.
- Keep all training up to date and retrain prior to expiration date.
- Work with hazardous materials (e.g., Isopropyl Alcohol, Butanone).
- Work closely with various level manufacturing and support personnel in a dynamic and team oriented environment.
- Routinely and safely handle high value product vials in various stages of packaging completion.
- Use computer based systems for timecards, e-mail and inventory management.
- Performs general maintenance and repair as required on automated and Semi-automated machines used in packaging to ensure optimal operation.
- Reviews, revises and follows operational procedures, follow both written and verbal instructions from the supervisor.
- Periodically check and maintain flammables cabinet, satellite hazardous waste accumulation station.
Qualifications
- Required: This is a day time position with occasional weekend work.
- Required: High School Diploma / GED.
- Required: 2-3 years working in a packaging, or equivalent manufacturing environment.
- Preferred: Demonstrated basic math skills and communication skills.
Education
- High School Diploma / GED
Additional Requirements
- Packaging operations require gowning consisting of hairnet, beard cover, lab coat, gloves, safety glasses, shoe covers and task specific personal protective equipment.
- Packaging operations require retrieval (and subsequent storage) of product vials from a 2-8°C cold room.