Technical Operations I, Liquid Dose Manufacturing
The Technical Operations I colleague will primarily be responsible for the cleaning and sanitization of the Liquid Dose Manufacturing (LDM) suite, Andover Clinical Manufacturing Facility (ACMF) and the Cell Banking Suite (CBS). This position will be performing and learning basic techniques, processes and operations. The work is performed in strict compliance with manufacturing standards and all regulatory requirements. They will be responsible for completing all OJT's and tasks required to perform job duties which include documentation, computers, equipment, work practices within aseptic areas. The incumbent with demonstrate the ability to properly problem solve work-related issues, work with an appropriate level of independence, exercise good judgment/decision making, and effectively work with team members
- Sanitization of the Liquid Dose Manufacturing (LDM) Suite, Cell Banking Suite, and Andover Clinical Manufacturing Facility (ACMF)
- Maintaining LDM facility and ACMF equipment in clean, validated working order to be available for the manufacture of drug product according to cGMPs.
- Supporting/performing support operations in the manufacture of clinical drug product according to approved batch records.
- Responsible for supporting the operation of complex pieces of drug product manufacturing equipment.
- Generating SCADA reports, maintaining logbooks and other documentation as assigned.
- Communicating with peers, supervisors, and interdepartmental groups to provide for an efficient drug production process.
- Remain current on all training requirements and for completing all required procedural and skills training (ILT, OJT, etc.) prior to executing assigned tasks.
- Ensure a safe work environment, and attend training and health/safety courses per job requirements.
- Responsible for visual inspection of drug product vials
- Maintaining qualification for use of Personal Air Purifying Respirator
- High School Diploma or GED Required with 0-2 years of experience working in a GMP environment
- Must have experience following and executing approved SOP's in a regulated environment
- Work must be performed in strict compliance with manufacturing standards and all regulatory requirements.
- Associate's or Bachelor's Degree in Biology, Chemistry or Life Science concentration.
- 0-2 years of experience working in a regulated environment on a 3rd shift
- Must be able to pass sterile gown qualification.
- Job tasks may include frequent bending, lifting of up to 50lbs, and twisting motions.
- Ability to stand upright for several consecutive hours.
- Must be able to pass medical clearance for use of Personal Air Purified Respirator.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENTAL REQUIREMENTS
- Normal operations to be performed during third shift (11pm – 7:30am) some overtime work may be required.
- Most work performed in a Grade A and C controlled environment under cGMP regulations.
Other Job Details:
- Eligible for Employee Referral Bonus: Yes