Manufacturing Engineer II

SGS Consulting; Boston (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

SGS Consulting is seeking a validation-focused engineer to develop and maintain equipment validation protocols (IQ/OQ/PQ) for medical devices. You will lead troubleshooting and data analysis to improve manufacturing yield and reduce downtime, while coordinating with Manufacturing, Regulatory, and Quality Assurance teams.

The ideal candidate brings 4–6 years in medical device/pharma manufacturing, a BS in Engineering, and a PE or Lean/Six Sigma credentials.

Qualifications

• 4–6 years of experience in medical device/pharmaceutical manufacturing.
• Professional Engineer license preferred.
• Lean/Six Sigma training a plus.

Responsibilities

• Create, update, and maintain equipment service work instructions.
• Lead validation plans and protocols (IQ/OQ/PQ) and prepare reports.
• Support troubleshooting to minimize downtime and re-occurrence.
• Analyze data to drive manufacturing yields and improvements.
• Develop and implement change controls and CAPA investigations.
• Coordinate with cross-functional teams for regulatory submissions and audits.

Skills

FDA/OSHA/ISO requirements

Lean Six Sigma

Manufacturing Equipment

Project Management

Validation Plans/Protocols

Change Control/CAPA

Education

BS in Engineering

Professional Engineer License

Lean/Six Sigma Green/Black Belt

Job description

Job Responsibilities:

Create, update, and maintain equipment service work instructions.Organize and write validation protocols associated with the manufacturing processLead and support troubleshooting activities to minimize process downtime or re-occurrenceIdentify key process indicators and collect data to drive manufacturing and yield improvementsResponsibilities: 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 requirementsLean Manufacturing/Six Sigma or Black BeltManufacturing EquipmentProject ManagementValidation Plans/Validation ProtocolsChange 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.