Coating Operator

Responsibilities

• Set up, operate, and monitor tablet coating equipment and related systems to ensure consistent product quality and process performance.
• Perform advanced troubleshooting, equipment adjustments, and cleaning activities in accordance with validated procedures and SOPs.
• Conduct in-process testing, sampling, and inspections per Master Batch Records (MBRs), ensuring all documentation meets data integrity standards.
• Lead or support complex changeovers, coordinating with Quality, Technical Services, and Engineering to ensure readiness for subsequent operations.
• Review batch records for accuracy and completeness, identifying and correcting documentation errors as needed.
• Mentor and train Manufacturing Associates in equipment operation, cGMP compliance, and best practices for safe, efficient production.

Requirements

• A high school diploma or equivalent required; technical school certificate or coursework in manufacturing or related field preferred.
• A minimum of 5 years of pharmaceutical manufacturing experience in a cGMP-regulated environment.
• Demonstrated proficiency in three or more OSD manufacturing processes, including coating, blending, compression, or encapsulation.
• Proven ability to troubleshoot and optimize equipment performance while ensuring adherence to quality standards.
• A strong understanding of cGMP, FDA regulations, and data integrity principles.
• Excellent attention to detail, documentation accuracy, and teamwork skills.
• Effective communication abilities and a strong commitment to safety and compliance.

Qualifications

None specified.

Skills

Not specified.

Benefits

• 401(k) with company match
• Health, vision, and dental Insurance
• Childcare expense reimbursement
• Tuition reimbursement
• Annual bonus eligibility
• Annual merit increases
• Paid Time Off and Flexible Holidays

Pay

N/A

Schedule

N/A