We are currently searching for a Process Engineer to join our team.

POSITION SUMMARY

This position will be responsible for providing primary engineering support for all Packaging, visual inspection, and support Packaging line and product transfers. It will support Packaging startup and commissioning activities.  This position will also support other areas of the facility as the business needs dictate. The ideal candidate will use GMP industry best practices and their expertise to measure, analyze and specify requirements that lead to best-in-class quality products and design for manufacturability. We are looking for a highly motivated candidate who can work cross-functionally in a highly regulated GMP compliant environment.

IMPACT AND ORGANIZATIONAL CONTRIBUTION

• Act as Packaging system owner during start up activities
• Lead and support Packaging implementation and improvements.
• Support the implementation and use of PAS-X.
• Support generation, review, and approval of Packaging SOPs.
• Support deviations/change controls associated with Packaging line and product transfers.
• Lead projects relating to the development and optimization of Packaging processes, including plant design, process equipment/workflows, and material handling.
• Evaluate existing Packaging processes and for improvements in capacity, efficiency, and product quality in alignment with business needs.
• Improve testing methods and quality control measures, incoming materials, standards, and controls.
• Develop user requirements for new capital equipment, survey potential equipment suppliers, submit RFQs, evaluate proposals from suppliers, and provide recommendations for purchase.
• Develop and execute test protocols and reports to validate new or modified processes.
• Strong ability to investigate root causes of Packaging issues impacting product quality or yield, support implementation of improvements, countermeasures, and preventative action.
• Identify sources of variation (procedure, process, equipment, people) within the Packaging process and design solutions.
• Recognizes the need for and embraces the concept of continuous improvement. Creates innovative ideas and recommendations based on engineering data, facts, and observations.
• Collects process data and performs trending and statistical evaluation to monitor process performance to understand stability and areas for improvement.
• Effectively partners with and motivates enabling support teams to improve operations for the advancement of the entire site and company.
• Maintain quality control and safety standards.
• Actively contributes to meeting business objectives around compliance, cost savings, and potential capital spending requirements.
• Assists in completing validation activities as required.
• Assists in non-conformance and CAPA investigations.
• Assist in training and development of team members.

EDUCATION AND EXPERIENCE

• BS in an Engineering discipline with 6+ years of experience.
• Food and Drug Administration, USDA, and/or work in a regulated manufacturing environment, preferably in aseptic manufacturing or Packaging, or medical device industry, is required.
• Proven experience in the application of engineering principles to the design and improvement of manufacturing processes.
• Experience working with GMP contract manufacturing organizations and third-party suppliers.
• Experience with pharmaceutical equipment and test method validation is preferred.
• Experience with Operational Excellence tools such as DMAIC, 5 WHY’s, Fishbones, FMEA, etc.
• Green belt or Black belt certification is a plus.
• Demonstrated ability to interact effectively with colleagues and management across departmental boundaries.
• Candidates must possess flexibility and agility to respond to constantly changing conditions and priorities.
• Proficient computer skills such as PAS-X or electronics batch record (EBR/MES), Excel, Word, MS Visio, JMP, Minitab, SAP, or similar software
• Must be willing to quickly learn and become proficient in common systems used to manage the business – to include production schedule, quality deviations, ERP system, and change control.

Work Environment: Colleague must work onsite, be able to lift at least 50 pounds, and work near moving mechanical parts with moderate noise level where the use of hearing protection is optional, and eye protection is required.

 This position is eligible for short-term incentive compensation.

 We offer a competitive and comprehensive benefits package, which includes healthcare, dental coverage, and retirement savings benefits along with paid holidays, vacation, and disability insurance.