Engineering Asset & Reliability Manager (GMP)

Resilience; West Chester (Chester County); On-site; USD 105,000 - 139,000; Full time

Benefits offered by this job

Relocation assistance

Annual bonus program

Comprehensive health benefits

Job summary

Resilience is a technology-focused biomanufacturing company focused on sustainable end-to-end manufacturing solutions. The Manager, Engineering will own a validated PET/Facility process, coordinate maintenance, and lead technical improvements.

The role requires collaboration with Operations, other Managers, engineering teams, and suppliers at the West Chester site. The position emphasizes ensuring regulatory compliance (EHS and GMP), asset reliability, and life-cycle management while developing

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: equipment, process/materials, maintenance, project delivery, automation/controls, and validation.

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.

Skills

GMP experience

Supervisory experience

FDA cGMP knowledge

Leadership

Problem solving

Cross-functional collaboration

Education

B.S. in Engineering or related field

Job description

Resilience is a technology-focused biomanufacturing company focused on sustainable end-to-end manufacturing solutions. The Manager, Engineering will own a validated PET/Facility process, coordinate maintenance, and lead technical improvements.

The role requires collaboration with Operations, other Managers, engineering teams, and suppliers at the West Chester site. The position emphasizes ensuring regulatory compliance (EHS and GMP), asset reliability, and life-cycle management while developing