The Senior Process Engineer is responsible for equipment/automation/process design, fabrication, and troubleshooting. Primary representative during vendor management, development, and approval of User Requirement Specifications (URS) of major manufacturing equipment identification and procurement. Perform periodic review of manufacturing equipment with Production and Facility personnel to identify areas for obtaining improved operational efficiencies.

• Process Management
  • Owner of periodic reviews of maintenance and validation activities for major production equipment to identify process improvement and efficiency projects. Includes review and data analytics of complex manufacturing systems.
  • Lead cross-functional teams to ensure production equipment maintains design requirements and meets operational goals and user needs.
  • Manages the URS, FAT, and SAT process for new production equipment.
• Equipment procurement
  • Mentors and assists other Engineers in the identification and procurement of manufacturing equipment and automation

• Ensures completion of design documentation (URS, FAT, and SAT) for new equipment procurement according to internal procedures and in accordance with industry standards (GAMP, ASTM E2500)
• Identifies, qualifies, and works with equipment vendors.
• Leads cross functional procurement team.
• Performs project management activities to ensure projects are on time, within budget, and successful.

• Validation
  • Supports validation engineers for equipment qualification.
  • Author, obtain appropriate approvals, and perform validation studies.
• Maintenance
  • Support maintenance staff to service equipment as needed.
  • Supplies troubleshooting support to help identify the causes of product/production related problems.
  • Design and implement process improvements and corrective actions.
• Process Design
  • Designs full-scale manufacturing equipment and/or processes for new products from R&D
• General
  • Read, understand, and comply with Good Manufacturing Practices and Standard Operating Procedures and accurately complete all required documentation per SOP requirements.
  • Perform all duties in accordance with safety rules as well as appropriate industry and regulatory guidelines.
  • Communicates clearly and effectively with department peers, manufacturing personnel, as well as supervisors, managers, and directors.
  • Assist and train employees on proper equipment operation.
  • Write and/or modify manufacturing and equipment related procedures as needed.
  • Update and maintain facility maps.
  • Other duties as assigned.

• A minimum of four years of experience in equipment procurement and/or process design.
• Previous experience in and FDA regulated production environment is desirable
• Must possess a working knowledge of the Metric System
• Advanced computer skills required (Word, Excel, CAD knowledge, PLC Database).
• Proficient in CAD. Solidworks and AutoCard experience preferred.
• Proficient in programming, specifically industrial control systems and ladder logic. RSLogix 5000 preferred.
• Thorough knowledge of electrical control systems.
• Proficient mechanical skills using diagnostic tools used to test, troubleshoot, and repair complex equipment.
• Ability to read/understand blueprints, schematics, wiring diagrams and other specialized documentation.
• Ability to read, understand and follow all company Standard Operation Procedures (SOPs) and guidelines.
• Adhere to safety SOPs and report potential safety hazards.
• Must have strong math skills.
• Must be a self-starter, detail oriented, organized, and able to perform under pressure in a fast-paced environment with minimal supervision.
• Excellent interpersonal, organizational, written, and oral communication skills.
• Ability to maintain regular attendance and punctuality requirements.
• Must be able to work overtime and weekends to support production efforts as needed.
• Must be able to work independently as well as collaboratively in a team setting with peers in a cross functional setting.
• Excellent analyzing, problem solving and troubleshooting skills