Process Engineer II

PCI Pharma Services-posted 4 months ago
Philadelphia, PA
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Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. The Process Engineer II role is focused on floor operations and eliminating waste to ensure a high-quality product is produced in a safe manner. The main functions of a Process Engineer are focused around five key activities of the plant for 1-2 value streams.

  • Identify and mitigate packaging issues for existing business through strong engineering and process improvement methods.
  • Provide technical leadership for new product launches.
  • Lead continuous improvement activities.
  • Specify, purchase, and commission new equipment and manage capital finances.
  • Provide technical support for new business (Sales/Business Development Support).
  • Analyze sales requests to determine equipment, tooling, or delivery systems needed.
  • Perform Engineering review of all components for new jobs (size, capability of equipment, bar codes).
  • Apply sound engineering principles to design new equipment, production lines and component layout.
  • Conduct and/or participate in customer meetings and attend occasional off-site meetings.
  • Interact with Sales and customers to determine requirements for new products/orders.
  • Participate in internal review meetings to plan new jobs with plant Operations, Maintenance, Quality, Purchasing and Process Engineering.
  • Prepare SOPs, line layouts, production line diagrams as needed.
  • Manage the Equipment Acquisition and Installation Process.
  • Negotiate & order equipment when approved.
  • Develop design criteria and equipment specifications, including safety, regulatory and necessary performance criteria.
  • Write protocols for URS, FAT, & SAT.
  • Lead SAT/FAT for all assigned projects.
  • Commissioning of equipment including all necessary change controls and training.
  • Research new trends and technologies in packaging; evaluate and test new equipment and processes.
  • Facilitate cross-functional Lean Six Sigma process improvement teams using a DMAIC method.
  • Measure and analyze performance metrics of the production area and spearhead initiatives to decrease variability and waste.
  • Bachelor of Science in Engineering or equivalent required.
  • 3-7 years relevant engineering experience.
  • Lean Six Sigma Background preferred.
  • Pharmaceutical and/or food packaging background preferred.
  • Familiarity with general industrial production equipment.
  • Familiarity with pharmaceutical packaging equipment such as Blister, Pouch, Bottle, Tablet Feeding, Carton and Carding machinery is highly desirable.
  • Effective communication skills (verbal and written form).
  • Ability to prepare a project plan.
  • Must possess and demonstrate motivational and leadership qualities.
  • Must possess excellent problem solving and analytical skills.
  • Must be well organized along with being detail and multi-task oriented.
  • Knowledge and experience in cGMP are desirable.
  • Knowledge of Lean and / or Six Sigma is a plus.
  • Fully competent in the use of computer software – Microsoft Windows, Microsoft Word, Microsoft Excel and Microsoft Power Point.
  • Ability to use Microsoft Project, Visio, and AutoCAD.
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