ClinLab Solutions Group
Coating Operator – Newtown, PA
Schedule: Monday - Friday, 1st shift (7am-3:30pm)
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.
Qualifications
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.
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Manufacturing
Industries Pharmaceutical Manufacturing
Benefits
Medical insurance
Vision insurance
401(k)
#J-18808-Ljbffr
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.
Qualifications
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.
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Manufacturing
Industries Pharmaceutical Manufacturing
Benefits
Medical insurance
Vision insurance
401(k)
#J-18808-Ljbffr