Operated tablet compression machines (Fette, Manesty, Korsch)
Hands-on experience with tablet/pill compression in GMP-compliant environments
Performed in-process quality checks: weight, hardness, thickness, appearance
Adjusted machinery settings based on in-process test results
Conducted equipment setup, changeovers, and troubleshooting
Cleaned and maintained compression/press equipment per SOP
Ensured compliance with cGMP, SOPs, and FDA regulations
Completed accurate batch records and production documentation
Strong mechanical aptitude; capable of basic equipment troubleshooting
Physically fit: able to lift 50 lbs, wear full PPE for extended periods
Detail-oriented with solid math and measurement skills
1–2+ years as a Compression Operator in solid oral dosage manufacturing
Familiar with encapsulation processes (preferred)
Experience working in FDA-audited facilities
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.
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.
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