Manufacturing Engineer II
Listed on 2026-10-18
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Engineering
Quality Engineering -
Quality Assurance - QA/QC
Quality Engineering
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.
FDA, OSHA, ISO requirements
Lean Manufacturing/Six Sigma or Black Belt Manufacturing Equipment Project Management Validation Plans/Validation Protocols Change Control/CAPA
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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