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Role Summary
Lead the Compression Group on the 2nd shift, ensuring the set-up and operation of compression/encapsulation equipment in accordance with SOPs and cGMP standards to produce quality pharmaceutical products. Supervise the department in the absence of the Supervisor, maintain a clean and organized workspace, and provide onโtheโjob training to junior operators.
Responsibilities
- Check tablets/capsules parameters hourly on all compression/encapsulation machines; maintain online documentation of all compression/encapsulation operations.
- Check and initial tablets/capsules data entered in PBR by operators; perform on-line review of PBR; inspect tablets for defects (sticking, chipping, capping) and encapsulation defects (dented capsules, logo erosion, empty capsules) during the run.
- Monitor room temperature and humidity as required by product specifications.
- Train and provide on-job training to junior operators on machine setup, initial sampling, and troubleshooting.
- Review batch folders after compression is completed; report discrepancies to Supervisor.
- Continue on-the-job training for Fette machine parameter setup with input from the Compression Equipment Mechanic/Supervisor.
- Ensure proper use of safety gear and dress code; keep the department neat, clean, and organized; supervise/manage the department in the Supervisorโs absence.
- Ensure operations comply with SOPs for Compression and Encapsulation; maintain knowledge of cGMP and required compliance.
- Weight variation, hardness and thickness checks.
Qualifications
- Experience: 7 years or more in Manufacturing/Pharmaceutical Experience
Skills
- Able to clean, set up and troubleshoot FETTE Tableting Machine and PAM/IIM Encapsulation Machine; complete Fette machine parameter setup training from Level 1 to Level 5.
- FETTE Tableting Machine Training Certificate Course up to Level 4.
- Ability to supervise, train and coach tableting staff on cleaning, setup, and troubleshooting FETTE machines.
- Knowledge of preventive maintenance of compression and encapsulation equipment.
- Flexible to work extended hours; strong attention to detail and accuracy.
Education
- Required: High School or GED HR Curriculum
Additional Requirements
- OSHA-compliant respirator fit test completion is required.