Manufacturing Specialist

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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.

Overall focus is manufacturing technical leadership for assigned area at the Birmingham site:  PDS Services, PDS Products, and MDS (Medical Devices). Strategic focus is unit operation and process owner for production processes in include range of customer needs. Ensure that the GMP capabilities (trained and proficient people, reliable and error proofed process, and consistent and compliant use of equipment and tools) are well integrated and execute flawlessly; assure operational readiness and compliance with EHS and Quality requirements specified in relevant regulations, Evonik’s standards, policies, and procedures:

• Environment, Health, and Safety
• cGxP practices
• Quality Compliance
• SOP development, review, and adherence
• Equipment documentation and control
• Project Management
• Customer service
• Equipment troubleshooting
• Input into CAPEX strategy

Knowledge of other related technical skills, methods, and manufacturing fields.

Possess and expand site technical skills and keep abreast of developments in field related to pharmaceutical compliance, manufacturing, and quality management systems.

RESPONSIBILITIES

• cGMP process and batch execution in clean room manufacturing activities.

• Responsible for manufacturing related regulatory compliance (FDA, EMA, IPEC, ISO, etc.), adherence to company and departmental goals and objectives, GDP activities, maintenance outages, etc., training of front line personnel, interaction with other department leads and company management, CMO readiness and process transfer, Leadership and accountability in the areas of manufacturing safety, training, environmental compliance, and area housekeeping

• Development of new training materials and maintaining current curricula for operational staff

• May require additional support activities for interaction with clients and / or client representatives (site tours, face-to-face client meetings). Support, training, and accountability in the area of regulatory compliance (FDA, EMA, IPEC, ISO, etc.) and standard operating procedures

• Seek out and identify opportunities for improvement in the areas of GMP document management, training, execution, deviation causal factors, and product release

• Execution of validation IOQ’s, PPQ, or other validations with minimal assistance from process engineering and validation.

REQUIREMENTS

• BA/BS Degree in STEM subject preferred.

• Relevant industry experience in pharmaceutical and/or chemical industry with production/manufacturing experience is required for higher level Specialist assignments.

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