Manufacturing Engineer III

1 month ago

Boston, United States Katalyst HealthCares & Life Sciences Full time

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.

Requirements:

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.Manufacturing equipment, manufacturing processes, stability or aging, required.

Minimum of 4-6 years of experience in the medical device and/or pharmaceutical manufacturing environment.

Knowledge in Organizational Excellence and Lean/Six Sigma.

Strong Project Management skills.

Ability to lead teams through complex projects and provide departmental technical leadership.

Must have excellent communication skills and a strong track record of working cross-functionally.

Must have demonstrated ability to think strategically.

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