Senior Packaging Engineer (cGMP - ISO 11607) JD817725
Boston, MA area
DPS is seeking a knowledgeable Packaging Engineer to work with a cGMP client in the Greater Boston, MA area. The ideal candidate will be responsible for the design, validation and implementation packaging materials, packaging equipment, and systems. The position interfaces with all departments to ensure materials and processes are compatible for technology transfer and consistent with established project plans and corporate goals. All activities are performed according to internal Quality System requirements, cGMP and ISO 13485 standards.
- Interact with packaging material vendors to evaluate and select cost effective packaging materials that meet industry standards for sterile barrier packaging systems.
- Manage capital projects including design, purchase, validation and implementation of equipment and packaging processes to meet project schedule and budgetary requirements.
- Identify calibration requirements and tolerances for new equipment and instruments.
- Prepare draft-operating procedures for new equipment and processes and work with Document Control to ensure final processes are implemented through the document mastering process.
- Develop/edit master part specifications and/or artwork specification to meet regulatory and marketing requirements.
- Perform process/product risk assessments and prepare reports according to company procedures.
- Prepare equipment (IOQ, PQ) and process validation (PV) protocols.
- Coordinate activity with the Packaging Department to execute equipment and process validations according to approved protocols.
- Bachelor's degree in Mechanical, Industrial, Manufacturing, or Electrical Engineering preferred, but consideration will be given to other engineering or technical degrees based on relevant experience.
- 8+ years of pharmaceutical project engineering and/or project management experience.
- Experience with medical device packaging equipment and processes
- Demonstrated experience with material, equipment, and process validation according to pharmaceutical and medical device industry standards.
- Knowledge of ISO 11607 (Sterile Packaging Certification).
- Previous experience with sterile barrier packaging systems, heat sealing, cartoning, and on-line barcode printing and coding is strongly preferred.
- Excellent equipment and process troubleshooting skills.
- Strong organizational skills, oral and written communication and team attitude.
Document Management Systems
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