Summary:
We are seeking a dedicated Manufacturing (Process) Technician to provide critical cleaning and sanitation support within an FDA-regulated manufacturing environment. This role requires a hands-on approach, ensuring cleanliness and compliance within production areas. The ideal candidate brings experience in pharma or medical device settings with an aseptic background and familiarity with cGMP Grade 8 or lower environments.
Responsibilities:
- Adhere to Good Manufacturing Practices (GMPs) and Code of Federal Regulations (CFRs).
- Report any discrepancies or quality concerns to the Team Leader or Production Supervisor.
- Ensure quality compliance with a "Right First-Time" mindset.
- Receive and prepare components for manufacturing, feed components into equipment, and perform sanitation tasks.
- Maintain and document accurate records, monitor performance metrics, and participate in daily performance meetings.
- Operate pallet jacks, wrap pallets manually, and use computer systems to manage material inventory and electronic batch records.
- Collaborate with cross-functional teams to identify and implement process improvements.
- Maintain availability of components and products to support continuous operations.
Additional Requirements:
- Team Collaboration: Work effectively in teams to complete operational tasks and contribute positively to the work environment.
- Initiative and Compliance: Take direction well, follow all policies and procedures, and demonstrate initiative in task completion.
- Physical Requirements:
- Regularly lift up to 35 lbs and push/pull objects requiring up to 50 lbs of force.
- Stand for long durations and perform physical activities including bending, reaching, climbing, squatting, and kneeling.
- Ability to work on portable stairs or ladders up to 6 feet.
Qualifications:
- Basic Qualifications:
- Associate degree with 2 years of experience, OR
- Technical school training with 2 years of hands-on experience, OR
- High school diploma/GED with 4 years of experience in a relevant field.
- Experience:
- Previous experience as a technician in medical devices or pharmaceutical environments.
- Familiarity with aseptic techniques and component preparation.
- cGMP experience in Grade 8 or lower environments is highly preferable.
Shift:
- Day Shift (7:00 am - 4:00 pm), with potential future shift adjustment to split shift (3:00 pm - 12:00 am).
- Flexibility for overtime is required.
