Position Summary
The Manufacturing Operator (2nd Shift) is responsible for operating and maintaining tablet compression equipment used in the production of solid oral dosage forms in a cGMP-regulated pharmaceutical environment. This role involves equipment setup, in-process testing, documentation, and cleaning. Training will be provided to ensure safe, accurate, and compliant operation on first shift (7:00 AM – 3:30 PM). The ideal candidate is mechanically inclined, detail-oriented, and committed to consistent product quality and safety.
Responsibilities
Operate tablet compression machines (e.g., Fette, Manesty, Korsch) in accordance with approved batch records and SOPs.
Monitor tablet weights, hardness, thickness, and appearance, and adjust as necessary.
Perform in-process checks and document all results accurately and in real-time.
Complete all batch-related documentation, logbooks, and records in accordance with cGMP standards.
Assemble and disassemble compression machines and associated tooling for product changeovers.
Clean and maintain equipment and work areas per standard operating procedures and cleaning protocols.
Assist with basic maintenance and promptly report mechanical issues or abnormalities to the supervisor.
Adhere strictly to safety protocols, cGMP guidelines, and company policies.
Accurately label, track, and document materials used during the compression process.
Support reconciliation, line clearance, and inspection readiness activities as needed.
Communicate effectively with Quality Assurance, Maintenance, and other Manufacturing staff to ensure efficient and compliant operations.
Participate in shift handovers and meetings to maintain production continuity.
Collaborate with teammates to meet daily production goals and timelines.
High school diploma or equivalent required.
Mechanical aptitude and willingness to learn equipment operation.
Strong attention to detail and the ability to follow written and verbal instructions.
Basic math skills for measurements and batch calculations.
Basic understanding of tablet compression principles and equipment preferred.
Prior cGMP knowledge is a plus.
Will be trained in encapsulation equipment operation, cleaning procedures, and documentation practices.
Commitment to following SOPs, batch records, and regulatory requirements.
Ability to lift up to 50 lbs. and perform repetitive tasks while standing for extended periods.
Must be able to wear required personal protective equipment (PPE) including gloves, gowns, and masks.
Ability to work in a fast-paced environment while maintaining accuracy and compliance.
This job description reflects general duties and responsibilities and is not intended to be all-inclusive.
Benefits
System One, and its subsidiaries including Joulé, ALTA IT Services, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan. System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law. #M3 Ref: #558-Scientific...is full-time at 36 hours per week, offers full benefits and a night shift schedule. There is an opportunity for overtime and to cover various... ...program for Certified Nursing Assistants; possesses state CNA Certification As of 8/1/2013, job requires a C.N.A. license...
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