PLS GMP Manufacturing Technician II

Key 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
• GMP Compliance & Quality: 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
• Equipment & Facility Support: 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
• Team Support: Collaborate effectively within cross-functional teams including QA, QC, and Facilities, Contribute to process efficiency improvements and lean manufacturing initiatives

Qualifications, Education & Experience

• 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)

Skills & Competencies

• 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

Physical/Mental Requirements

• Mobility to work in a lab and office setting, Use standard office and lab equipment and stamina to sit for extended periods of time, Exerting up to 20 pounds of force occasionally and/or up to 50 pounds of force frequently to lift, carry, push, pull or move objects, Vision to read printed materials and computer screens, Hearing and speech to communicate in person or over the telephone

Benefits

Full-time roles are eligible for our comprehensive benefits program which includes competitive salaries, medical, dental vision, 401K retirement savings plan (100% vested immediately in the employer match), life, disability and voluntary benefits, paid time off for holiday, sick and vacation days, HSA, wellness program, flexible spending accounts, tuition reimbursement, Employee Assistance program, parental leave, optional legal coverage and ID theft.