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Senior Manufacturing Process Engineer

2 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)

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