Position Summary 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. Duties and 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 Regulatory Responsibilities • Conduct business in a responsible manner that complies with all state, FDA, OSHA and HIPAA regulations, or otherwise as applicable Supervisory Responsibilities • N/A Experience • Experience in a GMP environment and in an approved laboratory under minimal supervision preferred Education • Associates Degree or High School Diploma with zero (0) to two (2) or more years of directly related experience. • Degree in other discipline (or lack of degree) may be considered if sufficient technical depth has been achieved from professional experience Knowledge, Skills & Abilities • 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 Physical Requirements • Ability to sit or stand for prolonged periods of time • Ability to lift and carry materials weighing as much as 50lbs