Manufacturing Operator III

About the role

Performs functions relating to the processing of drug products in accordance with established Current Good Manufacturing Practices (cGMP), customer requirements, and Standard Operating Procedures (SOP). Responsible for the safe and efficient execution of job duties while ensuring product compliance to established standards.

Responsibilities

• Operate equipment for two or more production processes, including Glatt fluid bed processor, Granulation, Blending, Compression Coating, Imprinting, Banding, and Encapsulation.
• Perform machine changeovers, cleaning, and setup as required.
• Troubleshoot and make adjustments to maintain production specifications.
• Ensure adherence to quality standards during the manufacturing process.
• Complete manufacturing documents with accuracy and completeness.
• Maintain compliance with appropriate SOPs and cGMPs at all times.
• Perform duties through proper and safe use of equipment, following all OSHA regulations and Equipment Manuals.
• Train or coach entry-level operators.
• May act as Team Lead in the absence of supervision.

Work Conditions

• Noise: Sufficient noise, either constant or intermittent, to cause marked distraction or possible injury to hearing.
• Fumes: Smoky or vaporous emissions, usually odorous, from combustion or chemical reaction.
• Odors: Unpleasant smells.
• Gases: Examples include carbon monoxide and ozone.
• Dust: Airborne particles such as textile dust, wood, and silica.
• Hazards: Danger to life, health, or bodily injury from moving mechanical parts, scaffolding, high places, burns, radiant energy, explosives, toxic chemicals, and electric shock.

Physical Requirements

• Regularly required to use hands to handle, feel, talk, and hear.
• Frequently required to stand, walk, sit, stoop, kneel, crouch, crawl, push, and bend.
• Capable of bending and lifting, moving, and/or carrying up to 50 pounds.
• Ability to navigate office, lab, and/or plant floor environments, including standing, walking, and reaching.
• Must have the ability to wear applicable personal protective equipment, including respirators, safety glasses/goggles, and safety shoes.

Qualifications

• High School/Trade School/Vocational School Diploma, GED, or equivalent.
• Forklift or other related equipment certification required.
• Excellent troubleshooting skills.
• Solid knowledge of cGMP and other pharmaceutical regulatory requirements.
• Solid knowledge of Occupational Health & Safety procedures.
• Strong math and computer skills, including MS Office and SAP.
• Strong interpersonal and communication skills (both verbal and written).
• English language proficiency at elementary 1 (comparable to CEFR basic A2) level.

Experience

• Minimum five (5) years of Production/Manufacturing experience.
• Minimum of three (3) years of experience in primary production processes.
• Minimum of two (2) years of experience in a secondary process.

Pay

The presently-anticipated base compensation pay range for this position is $25.00/hr to $32.00/hr. Actual base compensation may vary based on geographical location and experience.

Benefits

• Annual Performance Bonus Plan eligibility.
• Long Term Incentive Plan eligibility.
• Medical, dental, and vision coverage.
• Life insurance and disability insurance.
• 401(k) savings plan with company match.
• Flexible spending accounts and employee assistance program.
• Paid time off benefits, including vacation and sick time.