Manufacturing Specialist

Manufacturing Specialist

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.

RESPONSIBILITIES:

• 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.

The Evonik Group adopts an Equal Employment Opportunity (EEO) approach. Candidates are assessed based on their educational qualifications, experience, job competencies and potential and shall not be discriminated against on the basis of race, ethnicity, age, gender, religion, nationality, disability or sexual orientation or other classifications protected by local, state, or provincial regulations.