As a member of the Manufacturing Sciences and Technology (MSAT) team, the Process Development Engineer provides critical technical and operational support to consumable and cartridge manufacturing operations. This contractor role bridges new product implementation and process optimization to maintain high product quality, improve yields, and enhance manufacturing robustness. The role operates within a matrix organization, collaborating with cross-functional and multinational teams to ensure compliance, process capability, and product supply integrity.
Responsibilities:
Technical Support:
Continuous and Process Improvement:
Qualifications:
Hands-on experience in any of the following areas is highly desirable but not required:
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Responsibilities:
Technical Support:
- Provide hands-on support to troubleshoot manufacturing processes and drive improvement initiatives.
- Conduct product and process characterization, including capability studies and identification of critical parameters.
- Author and maintain Work Instructions and other production-related documentation in compliance with quality standards.
- Design and implement In-Process Controls (IPCs) to monitor CTQs during manufacturing.
- Develop and maintain CTQ-Scorecards to track performance against quality attributes.
- Lead or support root cause investigations using structured methodologies (e.g., Kepner-Tregoe, 5 Whys, Fishbone Analysis).
- Partner with cross-functional teams for specification development, process characterization, and material qualification.
- Plan and execute Design of Experiments (DOE) and perform statistical analysis using tools such as JMP or Minitab.
Continuous and Process Improvement:
- Lead strategic improvement initiatives targeting cost reduction, yield improvement, and process efficiency.
- Apply Lean Six Sigma methodologies and maintain up-to-date process risk documentation (e.g., pFMEA).
- Collaborate across the Roche network to share and implement best practices.
- Quality Mindset:
- Ensure compliance with Quality System requirements through document control, change management, and monitoring.
- Participate in and support audits, CAPAs, NCRs, and validation of methods and systems.
Qualifications:
- Bachelor’s degree or higher in Engineering (Biomedical, Chemical, Mechanical) or related discipline. Equivalent combinations of education and/or experience are acceptable.
- Minimum 5 years in medical device, IVD, or regulated manufacturing roles.
- Experience working in a GMP or ISO 13485 compliant manufacturing environment, with direct involvement in process validation (IQ/OQ/PQ) and technology transfer from R&D to Operations.
- Proficiency in DOE, SPC, and statistical tools (e.g., JMP, Minitab).
- Prior experience authoring and managing production documentation in ERP systems (e.g., SAP).
Hands-on experience in any of the following areas is highly desirable but not required:
- Experience with microfluidics, surface chemistry, reagent formulation, or cartridge production.
- Biosensor or semiconductor manufacturing, especially processes involving functionalized surfaces.
- Automated liquid handling, reagent dispensing, and precision fluidics.
- Working in a cleanroom environment.
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