Senior Manager, Manufacturing Engineering (Blue Ash - IDAP)

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 Senior Manager, Manufacturing Engineering & Maintenance is the primary owner for all assets and is responsible for ensuring operation and maintenance of one technical process within operations. This includes scheduling of all maintenance activities, coordination of technical resources and technical trouble shooting. This position requires extensive collaboration Operations and other Senior Managers of Engineering & Maintenance, as well as Engineering, and OEM 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 be located at the new Blue Ash manufacturing site. The Blue Ash site will be focused on commercial production in the following areas: Inspection, Device Assembly, and Secondary Packaging (IDAP). Individual will lead a technical team of engineers and maintenance technicians to support IDAP - unique role due to its combination of technical expertise and people management.

Position Responsibilities

• Ensure there is one validated technical process with critical process parameters, material fit for use, material specs and operating procedures are clear and delivers a capable process.
• Own asset reliability and availability and PM content, effectiveness, and performance.
• Own life cycle management of manufacturing assets and development of project justification and engineering proposals.
• Provide technical guidance, career development and performance management to Technical team managers and engineers.
• Ensure proper technical support (mechanical and electronic) is available for all manufacturing and 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 OEE 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 Operations/Engineering/Maintenance/ Controls for new and existing processes/equipment.
• Work collaboratively with manufacturing/facility as well as with other engineers across Resilience and client networks.
• Author and review documents including Standard Operating Procedures, Batch Records, Material specs, 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, and controls and automation and are consistent with engineering standards.
• Key contact for regulatory inspections as process owner.

Minimum Qualifications

• Significant experience leading a technical team.
• Previous experience with predictive maintenance concepts.
• Proficiency in all the following disciplines: process/materials, maintenance, project delivery, controls.
• Proven ability to work with all levels with the organization - locally and globally.
• Ability to challenge and adapt current approaches/ways of working.

Preferred Qualifications

• Bachelor's degree in Engineering, Science or a related discipline.
• Significant experience in GMP or regulated production environment .
• Expertise in two more of the following disciplines: equipment, process/materials, maintenance, project delivery, automation, and controls.
• Experience supporting day-to-day commercial operations.
• Experience leading projects.
• Experience in Six Sigma/ analytical trouble shooting skills.
• Experience working in a Lean manufacturing environment.

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.