Job Description

Schedule: Monday - Friday, 1st shift (7am-330pm)

Coating Operator – Newtown, PA

The Coating Operator will serve as a senior, highly skilled production operator responsible for performing complex equipment setups, operations, troubleshooting, and changeovers in support of oral solid dosage (OSD) manufacturing. This role will focus primarily on coating operations while maintaining cross-functional capability across other key processes such as blending, compression, and encapsulation. The ideal candidate will bring extensive hands-on experience in pharmaceutical production, a deep understanding of cGMP compliance, and the ability to train and mentor junior operators.

This position’s responsibilities will include, but not be limited to the following:

• 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.
• We are looking for applicants with: High school diploma or equivalent required; technical school certificate or coursework in manufacturing or related field preferred.
• Minimum 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.
• 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.

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