Cleanroom Operator

Performs highly technical operations in the manufacturing and processing of pharmaceutical medical devices. Sets up, operates, maintains, and troubleshoots equipment. May include complex and precision adjustments requiring understanding of the manufacturing process and the effect of electronic, pneumatic and mechanical devises on the process. A strong focus and high attention to detail is required.

Requirements

• Responsible for following safety policies and procedures.
• Responsible for following Clean Room gowning procedures.
• Responsible for following Clean Room material handling procedures.
• Ability to maintain combo device documentation accurately is required
• Responsible for following all required GMP's and applicable manufacturing procedures.
• Ability to understand and follow pharmaceutical device procedures
• Shows the ability to consistently meet daily production goals while building a high quality product, part or subassembly to specification.
• Perform a variety of duties to process all types and sizes of product, components, and sub-assemblies using a variety of standard and specialty machines or hand operations.
• May be required to inspect for appearance, gauging of parts by “no-go” or “go” gauges and set fixtures.
• Awareness and understanding of environmental hazards in work area.
• Works with Production Clerks to help facilitate inventory accuracy.
• Follow department procedures on material replenishment.
• Provide assistance to MOB engineering including MRB investigations and ESM production.
• Assists in training of manufacturing personnel.
• Participate in continuous improvement activities to enhance team performance.
• Must be able to work flexible hours and report to work on a regular punctual basis.
• Ability to work in a team environment and work well with others.
• Reports malfunction of equipment or process deviation in a timely manner.
• Responsible for following Clean Room gowning & material handling procedures.
• Other related duties as assigned.

Benefits

• Medical, dental and vision insurance
• 401(k) plan with company match
• Paid time off
• Short-term and long-term disability insurance
• Life insurance
• Employee assistance program