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The Manufacturing specialist acts as primary production process owner and subject matter expert (SME) for manufacturer of final products in Birmingham Labs, PDS Services. Responsibilities include managing procedures, batch documentation, data and information, reporting and analysis. Short term growth of staff working in assigned area and unit operations: assure technical knowledge, proficiency, and compliance is embedded as part of training, training material, GMP documentation, job aids, and others as needed. This role provides manufacturing technical leadership for assigned areas at the Birmingham site, including PDS Services, PDS Products, and Medical Devices (MDS). The position serves as the unit operation and process owner, ensuring production processes meet a broad range of customer needs while maintaining high standards in GMP compliance, EHS, and quality. Key responsibilities include driving operational readiness, managing SOPs, ensuring equipment reliability, supporting customer service, contributing to CAPEX strategy, and troubleshooting. The role also requires staying current with industry developments in pharmaceutical manufacturing and quality systems.
Job Responsibility:
Execute cGMP batch manufacturing processes in cleanroom environments
Ensure regulatory compliance (FDA, EMA, IPEC, ISO) within manufacturing operations
Train frontline personnel and support development and maintenance of training materials and curricula
Lead safety, environmental compliance, and housekeeping initiatives in manufacturing areas
Collaborate cross-functionally with internal departments and management on production readiness and process transfer activities
Support CMO readiness and participate in client interactions, including site tours and meetings
Monitor and improve GMP documentation practices, training effectiveness, deviation root cause analysis, and release processes
Ensure adherence to Good Documentation Practices (GDP) and support maintenance shutdowns as needed
Execute validation activities (IOQ, PPQ) with minimal supervision
Identify and implement continuous improvement opportunities in manufacturing systems and processes
Requirements:
BA/BS Degree in STEM subject or combination of education and experience relevant to the position or AA/AS Degree in related subject and 2-4+ years experience relevant to the position
High School Degree in related subject and 4+ years experience relevant to the position
Strong understanding of cGMP, GDP, and regulatory standards (FDA, EMA, etc.)
Experience with cleanroom operations and batch execution
Proven ability to support or lead training programs for manufacturing staff
Familiarity with validation protocols and regulatory expectations
Strong communication and cross-functional collaboration skills
Detail-oriented with a focus on compliance and continuous improvement
Ability to work in a regulated environment with changing priorities
Flexibility to train on day shift and transition to assigned shift schedule as needed