Job Description

Job Responsibilities:

• Create, update, and maintain equipment service work instructions.
• Organize and write validation protocols associated with the manufacturing process
• Lead and support troubleshooting activities to minimize process downtime or re-occurrence
• Identify key process indicators and collect data to drive manufacturing and yield improvements
• Responsibilities: Generation and execution of validation plans, validation protocols (IQ/OQ/PQ), and completion reports, with a major focus on sterilization and microbiology of medical devices.
• Provide statistical analysis of the date to support the reports.
• Generation and implementation of change controls and engineering notices (ECO).
• Develop statistically based sampling plans for in-process and final testing and inspections, and validations.
• Troubleshooting equipment/processes that do not perform as intended during validation runs. Recommend process/quality improvements as part of validation runs.
• Evaluate, investigate, and document non-conformances incidents and/or protocol deviations.
• Complete assigned Non-Conformance and CAPA investigations and prepare investigation reports.
• Develops and maintains an effective cross-functional working relationship with plant and corporate Manufacturing, Engineering, Regulatory, and Quality Assurance personnel.
• Work on project teams with other internal departments, external vendors, and customers as required.
• Assure that existing processes and assigned activities fully comply with regulatory and/or international agencies, such as FDA, ISO, OSHA, EPA, among others.
• Participate in the compilation and review of technical documentation for both domestic and international regulatory submissions. Participate in external audits such as: FDA, Notified Body (BSI) and Corporate, among others. Performs other related duties as necessary.

Skills:

• FDA, OSHA, ISO requirements
• Lean Manufacturing/Six Sigma or Black Belt
• Manufacturing Equipment
• Project Management
• Validation Plans/Validation Protocols
• Change Control/CAPA

Education/Experience:

• BS in Engineering, preferably Mechanical, Industrial, Electrical, Chemical, or Biomedical (Professional Engineer License.) or sciences related field.
• Lean/Six Sigma Green or Black Belt Certification is a plus.
• Minimum of 4-6 years of experience in the medical device and/or pharmaceutical manufacturing environment.

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