Manager, Engineering

Position Responsibilities

• Ensure there is one validated technical process with critical process parameters, material fit for use; material specifications and operating procedures are clear and deliver a capable process.
• Own asset reliability, availability, PM content, effectiveness, and performance.
• Own life cycle management of PET/Facility assets and development of project justification and engineering proposals.
• Provide technical guidance, career development, and performance management for engineering and technical personnel.
• Ensure proper technical support (mechanical and electronic) is available for all PET/Facility activities across all shifts.
• Ensure documentation and systems are updated and maintained.
• Ensure adherence to EHS and GMP compliance and improvements.
• Participate in risk analysis of spare parts inventory.
• Drive and support improvement initiatives.
• Maintain external technical relationships and collaborates with equipment and material suppliers.
• Supports technical trouble shooting.
• Initiate deviations of machine failures, drive root cause analysis, and perform/facilitate technical investigations and assessment of impacts including implementation of CAPAs.
• Identify technical training requirements of Operations/Engineering/Maintenance/Controls for new and existing processes/equipment.
• Works collaboratively within PET/Facility as well as with other PET Engineers and MSAT teams.
• Author and review documents including Standard Operation Procedures, Batch Records, Rework procedures, Material Specifications, and other forms.
• Author and review validation and change control documents such as master plans, protocols, summary reports, and change requests.
• Provide input and develop user requirements for new asset procurement.
• Provide input to engineering projects as a subject matter expert in maintenance, electronics, controls and automation and are consistent with engineering standards.
• Key contact for regulatory inspections as technical process owner.

  Minimum Qualifications

  • Experience in GMP or regulated production environment
  • Previous supervisory experience
  • Knowledge of FDA cGMP
  • Strong communication and leadership skills
  • Problem solving skills
  • Expertise in two or more of the following disciplines: equipment, process/materials, maintenance, project delivery, automation/controls, and validation

  Preferred Qualifications

  • Bachelor of Science in Engineering, Pharmacy, related Science or business.
  • Previous supervisory experience
  • Strong communication and leadership skills
  • Problem solving and project management skills
  • Ability to challenge and adapt current approaches/ways of doing things
  • Proven ability to work with all levels within and outside of the organization

  Pay

  Target base pay hiring range for this position is $105,000.00 - $138,750.00 per year. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge.