Title: Manufacturing Operation Tech
Duration: 12+ months contract
Location: Providence, RI
Shift Timing: 1:30 pm – 10:00 pm
Job Description:
This role primarily involves fabricating cell encapsulation devices for delivering proprietary cells, encompassing manufacturing of all components and final assembly of the finished device. The Successful Candidate will join the Device Manufacturing Team, collaborating closely with Device Process Development, Device Quality Control, and Device Quality Assurance Functions, as necessary. The position is based in Providence, R.I..
Key Responsibilities:
- Execute daily maintenance and startup activities of all manufacturing Unit Operations.
- Manufacture and assemble Medical Devices in an ISO 7/8 Environment, ensuring compliance with c.G.M.P.
- Procedures and all Cleanroom Practices in each Unit Operation.
- Complete and compile Batch Records in a manner that complies with c.G.M.Ps. / c.G.D.Ps., and all relevant Procedures.
- Comply with all Company Policies including Health, Safety, and Environmental Regulations, Personal Protective Equipment Requirements, and Standard Operating Procedures.
- Ensure upkeep of Manufacturing Areas to allow for a clean, safe, and organized Work Environment.
- Review and train to Work Instructions and other relevant documents on an as-needed basis.
- Prioritize and plan work activities, and adapt to changing Production Schedules and other conditions, as required.
- Participate in Process Capability Assessments, Process Validation Activities, Root Cause Investigations, Corrective and Preventative Actions, Physical Inventory, Cycle Counts, Variance Investigation and Reconciliation, and other Cross-Functional Activities, as required.
- Review all Manufacturing Documentation, including Assembly, Inspection, Test, and Packaging Procedures, and provide feedback.
Key Duties and Responsibilities:
- Support facility operation, taking direction from Facilities/Operations, Quality, EH&S, Materials Management, and the Release and Stability Laboratory.
- Follow SOPs, policies, and all other relevant work instructions to ensure the successful and compliant operation of the drug product facility.
- Clean the facility and process equipment.
- Enter data into log books.
- Maintain understanding of, and strict adherence to, cGMP requirements.
- Comply with all on-going training requirements.
Knowledge and Skills:
- Ability to follow verbal and written instructions in English.
- Visual Acuity.
- Ability to distinguish between the colors red, yellow, blue, and green.
- Ability to lift up to 50 lbs.
- Communication skills, as well as documentation skills.
- Basic computer skills and demonstrated ability to learn new systems and understand new technologies.
- Flexibility to support shift work as required. This position may require overtime, as needed, supporting operations on late or early production shifts.
Education and Experience:
- High School Diploma or GED.
- Typically requires less than 1 year experience or the equivalent combination of education and experience
Job Type: Contract
Pay: $30.00 - $34.00 per hour
Schedule:
Ability to Relocate:
- Providence, RI: Relocate before starting work (Required)
Work Location: On the road