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.
• Serve 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.
• Drive operational readiness, manage SOPs, ensure equipment reliability, support customer service, contribute to CAPEX strategy, and troubleshoot.
• Provide manufacturing technical leadership for assigned areas at the Birmingham site, including PDS Services, PDS Products, and Medical Devices (MDS).
• Stay current with industry developments in pharmaceutical manufacturing and quality systems.

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.
• A 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.
• Able to work in a regulated environment with changing priorities.
• Flexibility to train on day shift and transition to assigned shift schedule as needed.