Process Engineer III

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 Summary & Role

Contributing to the overall success of our novel gene and cell therapy approach in our new vector manufacturing facility in North Carolina’s Research Triangle. As a Process Engineer, you will have responsibilities for critical aspects of facility growth, process changes, and equipment support.  The focus of this position is to provide expert support and coordination of equipment selection from initial design through close out.  The position is responsible for engineering aspects concerning project leadership, execution (schedule, budget, scope, etc.) ensuring the completion of quality projects that meet cost, schedule, operational requirements and business needs, alignment with global engineering standards and practices. 

Job Responsibilities

• Leadership and execution of capital and/or operating expense projects from inception to completion ensuring safety, regulatory and quality compliance. This includes scope development, design, construction and commissioning of equipment, systems and facilities. Leadership and participation on project teams, assuring that projects are coordinated with team members and compliant with applicable policies/procedures.
• Be flexible and organized to maintain control of projects with shifting priorities. Remain open to different ideas and confirm approach/priorities with management.
• Support third party firms for equipment detailed design and commissioning and qualification (C&Q).
• Execute engineering change management, quality events (e.g. change control, corrective action/preventative action, etc.), and project close-out documentation.
• In collaboration with Quality Assurance, support the site strategy for equipment requalification and implementation of program.
• Provide engineering technical support to site operations and validation activities (FAT, SAT, IQ/OQ/PQ, PPQ) with creative approaches, as well as adaptation to corporate, site and/or industry standards/methodology. Diagnose technical issues and current practices and provides recommendation/solution for their correction.
• Responsible owner for development and maintenance of equipment drawings (P&IDs, PFDs, etc) and equipment lifecycle (URSs).
• Provide support to Facilities/Maintenance team for development of a spare parts program and identify spare parts for incoming equipment.
• Ensure potential safety hazards are identified/shared and effective actions are rapidly implemented.
• Embed the highest standards of compliance with our quality systems into the site’s day-to-day activities.
• Collaborate and participate in global engineering communities of practice
• Align site practices with global engineering standards and practices
• Must be willing to have a flexible schedule to support 24x7 manufacturing activities.

Minimum Qualifications

• Experience supporting biomanufacturing operations.
• Experience owning and executing change controls in a GMP environment
• Experience owning and investigating deviations
• Experience owning and executing CAPAs
• Experience owning, developing, and updating equipment and system specifications

Preferred Qualifications

• BS/MS in Engineering or a related field with 5+ years of experience in a technical engineering role or related areas (or a combination of education and experience) including direct experience in equipment design, procurement, FAT, SAT, and IQ/OQ.
• Minimum 3 years of experience in pharmaceutical/biotech manufacturing, design, or consulting environment, supporting upstream and downstream single use bioprocessing systems.
• Familiar with FDA and EU regulations and GMP standards. First-hand experience with agency filings and inspections is a plus.
• Prior cGMP cell or gene therapy manufacturing experience is highly desired.
• Experience supporting fill finish operations
• Demonstrated understanding of equipment and unit operations supporting upstream cell cultivation
• Demonstrated understanding of equipment and unit operations supporting filtration and purification

Other Ideal Personal Characteristics:

• Ability to work in a matrixed-team environment, meet deadlines, and self-prioritize and balance work from multiple individuals and multiple projects.
• High proficiency for problem solving in teams and as an individual contributor.
• Exceptional verbal and technical writing skills; ability to provide focus and clarity; able to handle confidential information and material appropriately.
• Independently motivated, detail oriented and good problem-solving ability.
• Excellent organizational skills sufficient to multi-task in an extremely fast-paced environment with changing priorities.
• Willingness to take on other tasks as needed to support engineering and facilities objectives.

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

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 equity, 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, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target base pay hiring range for this position is $85,000.00 - $126,250.00 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. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.