About the role
Job Summary:
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.
Job Responsibilities:
- 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.
Education and Experience Required:
- High School Diploma, GED, or a Minimum of one (1) year manufacturing or production related experience.
- A Minimum of 6 months medical device related experience**.**
Basic Qualifications:
- May be required to successfully demonstrate mechanical aptitude either through testing and/or job related experience, technical training or certification.
- Ability to read, write, interpret, comprehend and consistently follow specifications.
- Ability perform basic math calculations and use measuring devices and tools.
- Shows the ability to consistently meet daily production goals while building a high quality product, part or subassembly to specification.
- Basic computer knowledge & skills including Microsoft Excel
- Ability to successfully demonstrate visual accuracy through company-approved program.
- Meets or exceeds dexterity requirements as required for the role.
- Ability to get along with people and to be able to work in a team environment.
- Displays a positive attitude
- Must exhibit willingness to work on a team and promote teamwork among all employees.
- Ability to work flexible and/or extended hours.
- Willingness to rotate into different tasks and responsibilities.
Physical Demands:
- Ability to work under pharmaceutical processing conditions in a controlled cleanroom environment.
- Ability to work with chemicals for a full shift (excluding breaks) utilizing provided Safety Data Sheets (SDS) as required.
- Ability to work under magnification for a full shift (excluding breaks) as required.
- Ability to stand and/or sit for a full shift (excluding breaks).
- Ability to lift and move 35 lbs. (over 35 lbs. with assistance).
- Repetitive use of hands and fingers, including the ability to feel, reach with hands and arms and/or perform repetitive hand/wrist movement.
- Ability to sit, stand and walk to perform tasks and rotate throughout workstations.
- Ability to safely perform area-specific gowning procedures. These may include but are not limited to: Donning a smock or jumpsuit with zippers and/or snaps, sitting or standing (with a safety bar) to apply shoe covers over the top of shoes, applying gloves, walking over or around benches in the transition area, and bending, stooping, and reaching motions.
- Ability to utilize all area-specific PPE including but not limited to: eye protection, respiratory protection and hearing protection as required.
Work Environment:
May require some exposure to chemicals used in manufacturing processes. Some minor physical inconvenience or discomfort occasionally present in the work situation (moderate noise, disagreeable odors, etc.). Appropriate Personal Protective Equipment (PPE) will be provided and must be maintained by the associate.