Manufacturing Specialist

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.
• Your Application
• To ensure that your application is proceeded as quickly as possible and to protect the environment, please apply online via our careers portal . Further information about Evonik as Employer can be found at https://careers.evonik.com .
• Please address your application to the Talent Acquisition Manager, stating your earliest possible starting date and your salary expectations.
• Your Talent Acquisition Manager:
• Taran Singh [C]
• Company is
• Evonik Corporation

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