Manager, Engineering

Resilience; Port Union (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

Comprehensive healthcare package

Paid vacation and holidays

Tuition reimbursement

Job summary

Resilience, a technology-focused biomanufacturing company in Port Union, Ohio, is seeking a Manager of Engineering. The successful candidate will be responsible for ensuring the operation and maintenance of critical technical processes, collaborating closely with various teams, and leading improvement initiatives.

The ideal candidate should possess experience in a GMP environment, strong leadership skills, and hold a Bachelor's degree in Engineering or related fields. The position offers a competitive salary range of $105,000 to $138,750 annually, alongside a robust benefits package.

Qualifications

• Experience in GMP or regulated production environment.
• Strong communication and leadership skills.
• Expertise in maintenance, project delivery, automation, and validation.

Responsibilities

• Ensure operation and maintenance of technical processes.
• Provide technical guidance for engineering personnel.
• Manage life cycle of PET/Facility assets.

Skills

GMP experience

Leadership skills

Problem solving skills

Expertise in equipment/process/materials

Education

Bachelor of Science in Engineering, Pharmacy, or related Science

Job description

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 moreof 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.

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.

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. 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.