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Senior Manufacturing Process Engineer

5 months ago

Indianapolis, United States Accordance Search Group Full time

Job Description:


  • Establish, maintain and improve manufacturing processes and associated equipment and infrastructure
  • Support and continuous improvement of manufacturing processes including packaging operations and simple chemical processes
  • Development, execution and maintenance of verification and validation protocols to ensure that the processes are stable and capable and are meeting KPI for process capability
  • Calibration and maintenance of production equipment to support ongoing compliance and performance of the production line
  • Maintenance of PFMEAs, safety risk documentation and Work procedures and instructions associated with the production process
  • Ensure the manufacturing processes, product, and facility controls are compliant to ISO 13485 and local safety requirements
  • Lead reliability and quality investigations and non-conformance resolutions
  • Perform risk assessments (PFMEA) and root cause analyses and establish metrics (KPI) and control plans to mitigate risks
  • Specify, source, design, and qualify production manufacturing tools, equipment, jigs, fixtures & infrastructure as part of continuous improvement and ongoing maintenance of the production process
  • Participate in supplier assessment, qualification, and selection as it pertains to the production process
  • Create and maintain documents associated with the manufacture, packaging and testing of the new product. For example, work instructions, validation plan, and test reports.
  • Participate in cross-functional teams as the manufacturing representative for the site as required
  • Provide production and operations team with technical support on the new manufacturing processes
  • Comply with Quality Management Systems policies and procedures and Occupational, Health and Safety policies and procedures


Job Details:


  • Compensation: $130,000 base salary
  • 401k match
  • Medical, vision, dental benefits


Job Requirements:


  • MUST HAVE: 3+ years of production support or process development experience in chemical manufacturing or pharmaceutical industries
  • MUST HAVE: Proven experience applying process development principles to chemical products and processes within a cleanroom manufacturing environment
  • MUST HAVE: Experienced in project management, working autonomously/as a self-starter, and being self-motivated
  • MUST HAVE: LEAN Manufacturing experience
  • MUST HAVE: experience "bringing to life" product manufacturing - cradle to grave
  • Experience working in the medical device industry or similarly highly regulated quality assured environment
  • Working knowledge of SPC techniques and data analysis
  • Demonstrated ability to apply creative and practical thinking to solve complex problems
  • Tertiary qualifications in Manufacturing, Process, Mechanical, or Chemical Engineering
  • Ability and willingness to work in an on-site setting (Indianapolis, IN)