
Manufacturing Associate (Lee)
Sharp Sterile Manufacturing, Lee, MA, United States
The Manufacturing Associate performs all production operations in the areas assigned within the facility. Perform production support operations in areas assigned and support start-up, changeovers and tech transfer and routine manufacturing activities.
Operate process equipment such as tanks, clean in place skids (CIP/SIP), agitators, filtration devices, autoclaves, glass washers, integrity testing and other small equipment
Operation manual, semi-automatic and fully automatic isolated based aseptic filling lines
Perform aseptic operations in Clean Room environments
Prepare buffers, medias and other solutions, following written procedures and batch records
Perform process steps in coordination with other associates asking for help as needed so as not to perform steps without proper training/qualification
Adhere to scheduling changes and responds appropriately
Communicate with supervisor on issues regarding work orders or shifts in process parameters
Give input and make suggestions to improve process
Follow all GMP’s and EHS procedures
Attend and completes all assigned training
Ensure training plan is accurate and up-to-date
Complete all necessary documentation per the required GMP practices
The position requires up to 4 years’ experience in a GMP environment or proven ability in an approved laboratory under minimal supervision. An Associate's or Bachelor's degree or equivalent experience is required.
Operate process equipment such as tanks, clean in place skids (CIP/SIP), agitators, filtration devices, autoclaves, glass washers, integrity testing and other small equipment
Operation manual, semi-automatic and fully automatic isolated based aseptic filling lines
Perform aseptic operations in Clean Room environments
Prepare buffers, medias and other solutions, following written procedures and batch records
Perform process steps in coordination with other associates asking for help as needed so as not to perform steps without proper training/qualification
Adhere to scheduling changes and responds appropriately
Communicate with supervisor on issues regarding work orders or shifts in process parameters
Give input and make suggestions to improve process
Follow all GMP’s and EHS procedures
Attend and completes all assigned training
Ensure training plan is accurate and up-to-date
Complete all necessary documentation per the required GMP practices
The position requires up to 4 years’ experience in a GMP environment or proven ability in an approved laboratory under minimal supervision. An Associate's or Bachelor's degree or equivalent experience is required.