Manufacturing Technician I

SHARP STERILE MANUFACTURING LLC•Lee, MA

15h

About The Position

Perform 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 activities.

Requirements

High School Diploma or General Educational Development Test (GED)
Understanding of the basic FDA cGMP regulations
Verbal and written skills
Basic software application skills (Word, Power Point)
Able to follow detailed processing instruction
Accurately document all necessary documentation
Satisfactory audio-visual acuity
Ability to read and write English
Familiarization with technical issues in the area
Ability to work shift that covers a 24/7 operation
Ability to work shifts and off hours, as applicable
Ability to sit or stand for prolonged periods of time
Ability to lift and carry materials weighing as much as 50lbs

Nice To Haves

Manufacturing Technician I – Zero to one (0 -1) years’ experience in a GMP environment and in an approved laboratory under minimal supervision preferred
Manufacturing Technician II – One to two (1 -2) years’ experience in a GMP environment and in an approved laboratory under minimal supervision preferred

Responsibilities

Operate glass washers and autoclave
Prepare buffers, medias and other solutions, following written procedures and batch records
Operate process equipment such as tanks, clean in place skids (CIP/SIP), agitators, filtration devices, autoclaves, glass washers, integrity testing and other small equipment
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 mandatory training
Ensure training plan is accurate and up-to-date
Complete all necessary documentation per the required GMP practices
Participate in presenting the manufacturing areas in a state of audit readiness
Perform production operations following written SOP’s/BR’s in accordance with GMPs
Other duties as assigned
Conduct business in a responsible manner that complies with all state, FDA, OSHA and HIPAA regulations, or otherwise as applicable