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)