PLS GMP Manufacturing Technician II

Pace® Analytical Services•Norristown, PA

2d•Onsite

About The Position

The GMP Manufacturing Technician II is responsible for executing and supporting manufacturing, dispensing, and packaging operations for solid dose products (e.g., tablets, capsules, powders) in a current Good Manufacturing Practice (cGMP) environment. This role ensures all activities are performed in compliance with batch records, SOPs, and regulatory requirements, while maintaining high standards of data integrity, quality, and safety. The technician will operate and maintain solid dose manufacturing equipment and collaborate cross-functionally with Quality, Engineering, and Facilities teams.

Requirements

Associate degree or technical certification in a science or engineering-related field preferred OR High School diploma with relevant experience
4–5+ years of GMP manufacturing experience, preferably in solid dose / small molecule production
Strong understanding of: cGMP regulations, Solid dose manufacturing processes and equipment, Batch records, SOPs, and documentation practices
Familiarity with pharmaceutical manufacturing environments (oral solid dosage forms preferred)
Ability to operate and troubleshoot manufacturing equipment
Strong attention to detail and documentation accuracy
Mechanical aptitude and basic math skills
Effective communication and teamwork skills
Ability to follow detailed procedures in a regulated environment

Responsibilities

Perform dispensing, blending, granulation, compression, encapsulation, coating, and/or packaging of solid dose products
Execute GMP manufacturing activities in accordance with batch production records and SOPs
Document all manufacturing activities accurately in batch records and logbooks in compliance with GDP (Good Documentation Practices)
Operate and clean solid dose equipment such as: Blenders (V-blenders, bin blenders), Granulators (high shear/fluid bed), Tablet presses and encapsulators, Coating equipment, Sieves/mills and packaging lines
Adhere to all cGMP, FDA, and internal quality standards
Ensure all documentation is complete, accurate, and audit-ready
Identify and report deviations, and support investigations and CAPA activities
Assist in SOP development, revision, and continuous improvement initiatives
Perform equipment setup, changeover, and basic troubleshooting
Partner with Maintenance/Engineering on preventive maintenance and repairs
Ensure proper cleaning and line clearance to maintain compliance and prevent cross-contamination
Collaborate effectively within cross-functional teams including QA, QC, and Facilities
Contribute to process efficiency improvements and lean manufacturing initiatives