Manager, Engineering

Resilience; Olde West Chester (OH); On-site; USD 105,000 - 138,750; Full time

Benefits offered by this job

Annual cash bonus program

401(k) plan with company match

Health benefits (medical, dental, vision)

Paid vacation and holidays

Tuition reimbursement

Job summary

Resilience is looking for a Manager, Engineering to own the technical processes within their West Chester facility. This role involves collaboration with various teams, ensuring asset reliability, and compliance with regulations.

The ideal candidate will have experience in a regulated production environment and supervisory experience. A Bachelor of Science in Engineering or a related field is preferred, along with strong communication and leadership skills. This position offers a competitive salary and robust benefits.

Qualifications

• Experience in a GMP or regulated production environment.
• Expertise in two or more engineering disciplines such as maintenance, automation, and validation.
• Strong leadership and communication skills.

Responsibilities

• Oversee operation and maintenance of technical processes.
• Lead improvement initiatives and support technical troubleshooting.
• Maintain external technical relationships and collaborate with suppliers.

Skills

GMP experience

Supervisory experience

FDA cGMP knowledge

Problem-solving skills

Communication skills

Education

Bachelor of Science in Engineering or related field

Job description

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 troubleshooting.
• 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 maintain consistency with engineering standards.
• Serve as 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.
• Sponsorship or support for work authorization, including visas, is not available for this position.

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 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.

Requests for reasonable accommodation can be made at any stage of the recruitment process.

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.