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

401(k) plan with company match

Healthcare package

Paid vacation and holidays

Tuition reimbursement

Caregiving support

Job summary

Resilience is a technology-focused biomanufacturing company seeking a Manager, Engineering to own assets and lead maintenance for a PET/Facility process at the West Chester site. You will schedule maintenance, coordinate resources, troubleshoot, and drive improvements, collaborating with Operations, Engineering, and suppliers.

This role requires strong leadership, GMP knowledge, and the ability to work across shifts.

Qualifications

• Minimum qualifications include GMP or regulated production experience.
• Previous supervisory experience is required.
• Knowledge of FDA cGMP is essential.
• Strong communication and leadership skills are required.
• Problem solving skills are essential.
• Expertise in two or more disciplines: equipment, process/materials, maintenance, project delivery, automation/controls, and validation.

Responsibilities

• Ensure there is one validated technical process with clear critical parameters and SOPs.
• Own asset reliability, availability, PM content and performance.
• Oversee life cycle management of PET/Facility assets and project justifications.
• Provide technical guidance and performance management for engineering staff.
• Ensure technical support across PET/Facility activities and shifts.
• Maintain documentation and systems, and ensure compliance.
• Drive improvements and manage supplier relationships.

Skills

GMP experience

Supervisory experience

FDA cGMP

Communication skills

Leadership

Problem solving

Equipment

Process/Materials

Maintenance

Project delivery

Automation/Controls

Validation

Education

Bachelor of Science in Engineering, Pharmacy, related Science or 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 collaborate 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.

Benefits

Resilience offers employees a robust total rewards program including an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, paid vacation, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs.

Salary

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.

Resilience does not accept unsolicited agency resumes. Resilience will not pay any third-party agency or company that does not have a signed agreement with Resilience.

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.