Manager, Engineering (Relocation Assistance)

Note: This position will primarily support Inspection Operations at the West Chester Manufacturing Site.

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