Manager, Engineering

Resilience•West Chester, OH

9h•Onsite

About The Position

A career at Resilience is more than just a job – it’s an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made . We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. For more information, please visit www.resilience.com Position Description The Manager, Engineering will be the primary owner of all assets and is responsible for ensuring operation and maintenance of one technical process within the PET/Facility. This includes scheduling all maintenance activities, coordination of technical resources, and technical troubleshooting. This position requires extensive collaboration with Operations and other Managers as well as Engineering, and suppliers. Leads improvement initiatives as the technical expert and acts as the first line of support for all project related work. Note: This position will primarily support Inspection Operations at the West Chester Manufacturing Site.

Requirements

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

Nice To Haves

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

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.