Additional Information
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
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.
Position Summary & Responsibilities
The Process Engineer III leads improvement initiatives as the technical expert and acts as the first line of support for all project-related work. This role is responsible for maintaining strong relationships with Technical Operations and Quality areas, collaborating within Manufacturing and the Facility, and partnering with cross-functional engineers. The Process Engineer III serves as the single point of contact for technical process issues.
● Process Capability: 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.
● Continuous Improvement: Lead efforts in changeover reduction, yield improvements, OEE optimization, maintenance reliability, and waste reduction for automated pharmaceutical manufacturing equipment.
● Technology Transfer: Ensure success criteria for technology transfer and validation are clear and that processes are capable of merging into Manufacturing/Facility operations.
● Technical Documentation: Generate a variety of URS, FAT, SAT, commissioning, and IQ/OQ/PQ protocols and reports.
● Asset Management: Coordinate Manufacturing/Facility improvement initiatives that define equipment data, capabilities, utilization, efficiencies, and obsolescence; manage the full lifecycle of the asset.
● External Collaboration: Maintain external technical relationships and collaborate with equipment and material suppliers.
● Change Management: Identify, develop, and manage the implementation of change controls to improve processes.
● Risk Management: Perform and maintain risk management activities for both new and existing processes and equipment.
● Investigations: Initiate deviations and facilitate technical investigations and impact assessments. Address root causes identified in investigations.
● Documentation Review: Author and review documents such as SOPs, Batch Records, and Rework procedures.
● Quality Compliance: Review and approve validation and change control documents including master plans, protocols, summary reports, and change requests.
● Project Management: Provide engineering and project management services, including project justification and capital planning input.
● Training Support: Identify and support technical training requirements for Operations, Engineering, and Maintenance for new and existing processes/equipment.
● Validation Oversight: Perform routine validation and periodic review activities.
● Troubleshooting: Support and lead technical troubleshooting and provide on-call support as required.
● Regulatory Support: Serve as a key contact for regulatory inspections as the technical process owner.
● System Reviews: Participate in the annual product review and biennial critical systems review process.
● Process Control: Manage process validation required due to changes in validated manufacturing processes.
Resilience · - OH - West Chester