Engineering Manager — GMP Facilities & Asset Leadership

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

Benefits offered by this job

Annual cash bonus program

401(k) plan with a generous company”

Health care (medical, dental, vision)

Family building benefits

Life and disability insurance

Paid vacation

Paid holidays

Other paid leaves of absence

Tuition reimbursement

Support for caregiving needs

Job summary

RESILIENCE in West Chester, Ohio hires a Manager, Engineering to own and maintain a validated PET/Facility process. You will steer asset lifecycle, lead cross-functional teams, and ensure GMP/compliance while guiding technical staff across shifts.

The role focuses on process reliability, documentation, and improvements, with extensive interaction with Operations, Engineering, and regulatory bodies. This is a full-time, on-site leadership position.

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; 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 with equipment and material suppliers.
• Supports technical trouble shooting.
• Initiate deviations of machine failures, root cause analysis, CAPA implementation and assessment.
• Identify technical training requirements for Operations/Engineering/Maintenance/Controls.
• Work with PET/Facility and MSAT teams.
• Author/review SOPs, Batch Records, Rework procedures, Material Specifications, etc.
• Author/review validation and change control documents (master plans, protocols, reports).
• Provide input for new asset procurement as SME in maintenance/electronics/controls/automation.
• Serve as key contact for regulatory inspections.

Skills

GMP experience

Supervisory experience

FDA cGMP

Communication & leadership

Problem solving

Cross-disciplinary knowledge

Education

Bachelor's in Engineering/Pharmacy/Science/Business

Job description

RESILIENCE in West Chester, Ohio hires a Manager, Engineering to own and maintain a validated PET/Facility process. You will steer asset lifecycle, lead cross-functional teams, and ensure GMP/compliance while guiding technical staff across shifts.

The role focuses on process reliability, documentation, and improvements, with extensive interaction with Operations, Engineering, and regulatory bodies. This is a full-time, on-site leadership position.