Process Engineer II

Primary Responsibilities

• 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, with a goal of designing a process capable of low defects (less than 1%), high uptime (greater than 95%), low waste (less than 1%), and throughput better than estimate.
• 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.
• Specify, order, and commission tooling as required for launch activities.
• Manage the Equipment Acquisition and Installation Process Including: Specifies equipment needed, prepares RFQs (Requests for Quote), and obtains quotes from vendors. Writes CER’s (Capital Equipment Requests) for new equipment, including researching the justification. Responsible for managing project budget and timeline. Negotiates & orders equipment when approved. Develop design criteria and equipment specifications, including safety, regulatory and necessary performance criteria. Write protocols for URS’ (User Requirement Specifications), FAT’s (Factory Acceptance Tests), & SAT’s (Site Acceptance Tests). Responsible for determining OQ parameters to start validation. Approve validation protocols and MPI’s. Leads SAT/FAT for all assigned projects. Commissioning of equipment including all necessary change controls and training. Responsible for the administration, implementation, and project management of assigned projects, including using standardized methodology. Research new trends and technologies in packaging; evaluates and tests new equipment and processes. Coordinate with staff on development of new equipment performance requirements. Assist Validation with OQ and PQ (Operational and Process Qualifications) of new packaging business. Write and modify SOPs relating to the production area and assist in training of affected personnel. Lead CAPA (Corrective and Preventative Actions) investigations and actions. Initiate investigation activity and troubleshoot problems in packaging; discovers causes of non-conformance, i.e., slow throughput, poor quality and/or unsafe design. Write and execute engineering protocols as needed. Uses DOE (Design of experiments) to control variables while testing. Applies sound engineering principles to improve existing equipment, packaging design and processes by reducing waste, increasing throughput, reducing energy consumption or eliminating human interaction through automation. Facilitates cross-functional Lean Six Sigma process improvement teams using a DMAIC method. Responsible for the administration, implementation, and project management of new business, including conformance with customer requirements and equipment / process performance criteria. Measure and analyze performance metrics of the production area and spearhead initiatives to decrease variability and waste.

Secondary Responsibilities

• Specify, purchase, and commission new equipment and manage capital finances.
• Provide technical support for new business (Sales/Business Development Support).

Essential Duties And Responsibilities

• Analyzes sales requests to determine equipment, tooling, or delivery systems needed.
• Performs Engineering review of all components for new jobs (size, capability of equipment, bar codes).
• Applies sound engineering principles to design new equipment, production lines and component layout, with a goal of designing a process capable of low defects (less than 1%), high uptime (greater than 95%), low waste (less than 1%), and throughput better than estimate.
• Conducts and/or participates in customer meetings and attends occasional off-site meetings. Interacts with Sales and customers to determine requirements for new products/orders.
• Participates in internal review meetings to plan new jobs with plant Operations, Maintenance, Quality, Purchasing and Process Engineering.
• Prepares SOPs, line layouts, production line diagrams as needed.
• Specifies equipment needed, prepares RFQs (Requests for Quote), and obtains quotes from vendors. Writes CER’s (Capital Equipment Requests) for new equipment, including researching the justification. Manages project budget and timeline. Negotiates & orders equipment when approved. Develops design criteria and equipment specifications, including safety, regulatory and necessary performance criteria. Writes protocols for URS’ (User Requirement Specifications), FAT’s (Factory Acceptance Tests), & SAT’s (Site Acceptance Tests). Determines OQ parameters to start validation. Approves validation protocols and MPI’s. Leads SAT/FAT for all assigned projects. Commissions equipment including all necessary change controls and training. Manages the administration, implementation, and project management of assigned projects, including using standardized methodology. Researches new trends and technologies in packaging; evaluates and tests new equipment and processes. Coordinates with staff on development of new equipment performance requirements. Assists Validation with OQ and PQ (Operational and Process Qualifications) of new packaging business. Writes and modifies SOPs relating to the production area and assists in training of affected personnel. Leads CAPA (Corrective and Preventative Actions) investigations and actions. Initiates investigation activity and troubleshoots problems in packaging; discovers causes of non-conformance, i.e., slow throughput, poor quality and/or unsafe design. Writes and executes engineering protocols as needed. Uses DOE (Design of experiments) to control variables while testing. Applies sound engineering principles to improve existing equipment, packaging design and processes by reducing waste, increasing throughput, reducing energy consumption or eliminating human interaction through automation. Facilitates cross-functional Lean Six Sigma process improvement teams using a DMAIC method. Manages the administration, implementation, and project management of new business, including conformance with customer requirements and equipment / process performance criteria. Measures and analyzes performance metrics of the production area and spearheads initiatives to decrease variability and waste.

Qualifications

• 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).
• Effective at leading project teams and interfacing with customers and operations personnel.
• Ability to prepare a project plan.
• Motivational and leadership qualities.
• Excellent problem solving and analytical skills.
• 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.
• Full competence in the use of computer software – Microsoft Windows, Microsoft Word, Microsoft Excel and Microsoft Power Point.
• Ability to use Microsoft Project, Visio, and AutoCAD.