Manager, Engineering (Relocation Assistance)

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

Relocation Assistance Offered 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.

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

Equal Employment Opportunity

Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.

Sponsorship and Work Authorisation

Sponsorship or support for work authorization, including visas, is not available for this position.

Benefits

• Annual cash bonus program
• 401(k) plan with a generous company match
• 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

Compensation

Our 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.

Company Overview

RESILIENCE is a first-of-its-kind manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale. RESILIENCE will offer the highest quality and regulatory capabilities, and flexible and adaptive facilities to serve partners of all sizes. By continuously advancing the science of biopharmaceutical manufacturing and development, RESILIENCE frees partners to focus on the discoveries that improve patients’ lives.