GMP Manufacturing Specialist & Process Leader

4142 Evonik Corporation_4142; Birmingham (AL); On-site; USD 65,000 - 100,000; Full time

Job summary

Evonik Corporation in Birmingham is seeking a Manufacturing Specialist to serve as the primary production process owner and SME for final product manufacturing at Birmingham Labs and PDS Services. You will manage SOPs, batch documentation, data, training materials, GMP compliance, and help drive equipment reliability and CAPEX readiness.

The role requires cGMP knowledge, regulatory awareness (FDA/EMA), strong cross-functional collaboration, and a commitment to continuous improvement in a

Qualifications

• BA/BS in STEM or related field with 2-4+ years experience.
• Strong understanding of cGMP, GDP, and regulatory standards.
• Experience with cleanroom operations and batch execution.
• Proven ability to support or lead training programs for manufacturing staff.

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 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.

Skills

cGMP

GDP

regulatory standards

cross-functional collaboration

training programs

SOPs

data analysis

Education

BA/BS Degree in STEM

AA/AS Degree in related subject

High School Degree

Job description

Evonik Corporation in Birmingham is seeking a Manufacturing Specialist to serve as the primary production process owner and SME for final product manufacturing at Birmingham Labs and PDS Services. You will manage SOPs, batch documentation, data, training materials, GMP compliance, and help drive equipment reliability and CAPEX readiness.

The role requires cGMP knowledge, regulatory awareness (FDA/EMA), strong cross-functional collaboration, and a commitment to continuous improvement in a