Process Engineer III - Filling

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.

1. Proven Experience in GMP or regulated production environment

2. 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

3. Proficiency in at least one of the following disciplines: automation/ controls, aseptic/packaging equipment, process/materials, maintenance, validation

1. Bachelor's Degree in Chemical, Mechanical, Electrical, Industrial, Automation, Mechatronics, Bioengineering, Pharmaceutical Engineering, or related science.

2. Project management experience

3. Uses their insight to challenge and adapt current approaches/ways of doing things

4. Experience in Six Sigma/ analytical trouble shooting skills

5. Experience working in a LEAN manufacturing environment

6. Expertise in more than one of the following disciplines: automation/ controls, aseptic/ packaging equipment, process/materials, maintenance, validation

7. Ability to coach and mentor peers

Work Schedule: 8 hours - Monday- Friday with offshift support as needed. The work schedule listed reflects the employee's expected schedule at the time of hire. The Company reserves the right to modify work schedules at any time, with or without notice, based on business needs, operational requirements, or other considerations. Nothing in this description creates a guarantee of specific hours, days, or shift assignments.

The items described here are representative of those that must be met successfully to perform the essential functions of this job.

Keywords: Sterile Manufacturing, Biopharma MSAT, Asset Delivery, Aseptic Processing, Sterile Fill-Finish, CDMO, Technology Transfer (TT), Annex 1 Compliance, RABS, Isolator Technology, Process Validation (PV), Root Cause Analysis (RCA).

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.

As a requirement of this role, employees must have the ability to demonstrate and maintain gown qualification standards. Please review the video below, which outlines the most extensive process to gown within specific areas of Sterile Operations at Resilience, West Chester.