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Sr Manufacturing Engineer

Billerica, MA 01821

Posted: 05/31/2024 Employment Type: Contract Job Category: Engineering Job Number: 607067 Is job remote?: No Country: United States

Job Description


Top 3 technical  skills that are required for the role:
  1. Evaluate, develop, validate and implement manufacturing processes and process improvements for Medical devices or regulated industries
  2. Problem solving, root cause investigation, experience with CAPA
  3. understanding of lean manufacturing and six sigma tools

 

 

Education Required:
  • Bachelor of Science Degree in Mechanical Engineering, Packaging Science, or similar discipline.

 

Years’ Experience Required:
  • Minimum of 5 years in medical device or pharmaceutical industry in Manufacturing Engineering, Packaging or Quality Engineering.
  • Requires practical knowledge and demonstrated competence within manufacturing engineering, process development, packaging engineering typically obtained through advanced education combined with experience.
  • Knowledge and working experience of Lean manufacturing and six sigma practices
  • Knowledge and general understanding of ISO 11607 part 2, ASTM and ISTA package test methods is preferred



The Manufacturing Engineer will lead and support various process improvement and remediation activities. Activities to include but not limited to the following.
  • Fixture design, procurement, installation, validation
  • Process map, process development, time studies, line layouts
  • Labeling system set-up, system updates, documentation updates
  • Process validation IQ/OQ/PQ
  • Author, update, and execute engineering Protocols and closing Reports
  • Documentation PLM system updates (BOM, SOP, visual aids, drawings, Work instructions)
  • Conduct and support Root Cause Analysis, Measurement System Analysis, gemba walks, update PFMEA and control plans
  • Support and process Non-Conforming Material Reports (NCMRs), CAPAs and Audit Findings
  • Weekly reports, updates, administrative task (as needed)
  • Conduct testing (as needed)
  • Manufacturing and engineering support (as needed)

Minimum Requirements
  • Bachelor of Science Degree in Mechanical Engineering, Packaging Science, or similar discipline.
  • Minimum of 5 years in medical device or pharmaceutical industry in Manufacturing Engineering, Packaging or Quality Engineering.
  • Requires practical knowledge and demonstrated competence within manufacturing engineering, process development, packaging engineering typically obtained through advanced education combined with experience.
  • Knowledge and working experience of Lean manufacturing and six sigma practices
  • Knowledge and general understanding of ISO 11607 part 2, ASTM and ISTA package test methods is preferred

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Billerica, MA

Discover your next career opportunity in the vibrant area surrounding Billerica, Massachusetts! This bustling region offers a perfect blend of scenic beauty, historic charm, and abundant growth opportunities. From the picturesque hikes at Great Brook Farm State Park to the buzzing arts scene at The Brush Art Gallery and Studios, Billerica and its surroundings have something for everyone. Immerse yourself in the rich culture of the area, savor the local delicacies like freshly caught seafood and signature Boston cream pie, and catch a game at the iconic Fenway Park while working in this dynamic and exciting region. Explore our job listings today and take the next step towards a fulfilling career in this captivating area.

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.