Specialist Manufacturing 35419

With minimal supervision, support the execution of manufacturing/quality systems such as non-conformances, process validation, procedures, training, and new product introductions. Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations. May serve as primary production process owner for process support systems and assist with process ownership responsibilities on more complex process systems.

1. Initiate, revise, and approve manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner.
2. Assess process performance by observation of floor operations and review of performance data. Evaluate, plan, and implement solutions for process improvement opportunities.
3. Assist in the generation of training materials and may assist in providing training on scientific or technical aspects of the process.
4. Ensures that processes, and procedures are aligned with cGMP requirements and/or other applicable regulations.
5. Responsible for ensuring that risks are identified, assessed, and corrected to ensure the safety, purity, quality, and efficiency of the product(s) manufactured.
6. Responsible for ensuring that the Electronic Batch Record is aligned with the current process and may assist in providing training.
7. Assist with generation and the implementation of process validation protocols and reports.
8. Participate in regulatory inspections.
9. Participate in the NPI process to assess requirements for documentation, materials, training, and equipment modifications.
10. Assess, prioritize, support, and provide implementation and project management support for process or equipment modification projects.
11. Own Change Control and ensure implementation within the established goal.
12. Assist manufacturing change owner on CCRB packages impacting the process.
13. Participate in noncommercial activity runs to support the collection and analysis of process data.
14. Participate on the assessment or implementation of special projects or initiatives.

• →Own change controls for manufacturing process changes
• →Support major/trend deviation investigations throughout the whole lifecycle including Root Cause Analysis investigation, determination of Corrective/Preventive Actions, authoring process investigation reports, and presenting within regulatory inspections.
• →Support Risk Assessments exercises and Microbial assessment evaluations.
• →Led commercial campaign readiness and effectively communicate and collaborate with cross function areas.
• →Assist in the generation of training materials and assist in providing training on scientific or technical aspects of the process.
• →Provide commercial support when needed and assist on the floor troubleshooting.
• →Design, coordinate, and support execution of functional tests, water tests, and other runs to challenge process and operations during major changes, or campaign readiness. Generate technical protocols as needed.
• →Assist and provide guidance during MBR (Master Batch Record) creation/revisions.
• →Perform assessment to support process, automation, or equipment modification or implementation of special projects
• →Initiate, revise, and approve standard manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner.
• →Assess process performance and review of performance data. Evaluate, plan, and implement solutions for process improvement opportunities.
• →Complete assessments for CAPA applicability requests from other plants/sites
• →Complete assessment for new or changes in BOM's (Bill of Materials)
• →Serves as a peer-recognized specialist in at least one area, with overall responsibility for determining methodologies in that area.

1. Masters + 2 years of Manufacturing Operations experience OR Bachelors + 4 years of Manufacturing Operations experience OR Associates + 8 years of Manufacturing Operations experience OR High school/GED + 10 years of Manufacturing Operations experience.