Process Engineer III - Filling

Resilience•West Chester, OH

5d•Onsite

About The Position

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. At Resilience, we are building a first-of-its-kind biomanufacturing ecosystem to redefine how life-saving medicines are made. This role is an important part of our MSAT team, offering the unique opportunity to lead the technical commissioning and delivery of state-of-the-art sterile fill-finish assets, including advanced robotics and an isolator filling line. We are looking for mission-driven engineers to help us deliver with "First-Pass Accuracy" and industry-leading technical standards. This position will support MSAT as an Asset Delivery Team member. Once the Fill Line and supporting equipment approach commercial production, the position will transition to the Sterile Operations Execution Team on a Monday–Friday schedule with potential off-shift support as needed.

Requirements

Proven Experience in GMP or regulated production environment
Training or experience in the applicable following technologies: mechanics, hydraulics, pneumatics, vacuum technology, electronics, programmable logic controllers, HMI, Historian/reporting, computerized systems, vision systems, refrigeration, test equipment for electrical and mechanical trouble shooting, aseptic/controlled environment, unit operations, formulation, packaging, process validation, cleaning validation, technology transfer, change control, applied statistics
Proficiency in at least one of the following disciplines: automation/ controls, aseptic/packaging equipment, process/materials, maintenance, validation

Nice To Haves

Bachelor’s Degree in Chemical, Mechanical, Electrical, Industrial, Automation, Mechatronics, Bioengineering, Pharmaceutical Engineering, or related science.
Project management experience
Uses their insight to challenge and adapt current approaches/ways of doing things
Experience in Six Sigma/ analytical trouble shooting skills
Experience working in a LEAN manufacturing environment
Expertise in more than one of the following disciplines: automation/ controls, aseptic/ packaging equipment, process/materials, maintenance, validation
Ability to coach and mentor peers

Responsibilities

Ensure there is one technical process with centerlines, critical process parameters (CPPs), and material fit-for-use; ensure operating procedures are clear and deliver a capable process.
Lead efforts in changeover reduction, yield improvements, OEE optimization, maintenance reliability, and waste reduction for automated pharmaceutical manufacturing equipment.
Ensure success criteria for technology transfer and validation are clear and that processes are capable of merging into Manufacturing/Facility operations.
Generate a variety of URS, FAT, SAT, commissioning, and IQ/OQ/PQ protocols and reports.
Coordinate Manufacturing/Facility improvement initiatives that define equipment data, capabilities, utilization, efficiencies, and obsolescence; manage the full lifecycle of the asset.
Maintain external technical relationships and collaborate with equipment and material suppliers.
Identify, develop, and manage the implementation of change controls to improve processes.
Perform and maintain risk management activities for both new and existing processes and equipment.
Initiate deviations and facilitate technical investigations and impact assessments. Address root causes identified in investigations.
Author and review documents such as SOPs, Batch Records, and Rework procedures.
Review and approve validation and change control documents including master plans, protocols, summary reports, and change requests.
Provide engineering and project management services, including project justification and capital planning input.
Identify and support technical training requirements for Operations, Engineering, and Maintenance for new and existing processes/equipment.
Perform routine validation and periodic review activities.
Support and lead technical troubleshooting and provide on-call support as required.
Serve as a key contact for regulatory inspections as the technical process owner.
Participate in the annual product review and biennial critical systems review process.
Manage process validation required due to changes in validated manufacturing processes.