Process Engineer Iii Jobs

• Define, measure, analyze, and propose improvements to the current process and systems.
• Support and/or perform hands-on experiments in the manufacturing area as needed.
• Author and execute engineering studies, technical reports, change controls, deviations, and process validation protocols.
• Use FMEA or similar risk-based approaches to troubleshoot processing issues.
• Embed the highest standards of compliance with our quality systems into the site’s day-to-day activities.
• Ensure potential safety hazards are identified/shared and effective actions are rapidly implemented.
• Provide technical support of training, Engineering and GMP manufacturing runs and hands-on support as needed for rapid troubleshooting.
• Manage deliverables for technology transfer
• Leads cross functional teams for tech transfer and manufacturing support. May participate on sub-teams and work as a point of contact for other programs.
• Support MSAT and Manufacturing document drafting with a strong understanding of equipment, process control strategies, in-process testing, etc.
• Work closely with Manufacturing, Quality Assurance, and other functions to successfully resolve deviations, investigations, change controls, CAPAs, etc.
• Serve as the technical expert for the sterile fill/finish (thawing/pooling, sterile filling, inspection, and labeling) vector manufacturing process.

• Ability to work in a matrixed-team environment, meet deadlines, and self-prioritize and balance work from multiple individuals and multiple projects.
• Excellent organizational skills sufficient to multi-task in an extremely fast-paced environment with changing priorities.
• Exceptional verbal and technical writing skills; ability to provide focus and clarity; able to handle confidential information and material appropriately.
• Familiar with FDA and EU regulations and GMP standards. Experience with agency filings and inspections is a plus.
• Tech transfer and/or process validation experience.
• Independently motivated, detail oriented and good problem-solving ability.

• Experience in gene therapy or viral vectors
• BS (3+ years) or MS (0 – 3 years) in Engineering or a related field.
• Experience working at a CDMO or other service provider

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 annualized base pay hiring range for this position is $95,000.00 - $121,250.00. 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.