Process Engineer IV, MSAT Device
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
The Process Engineer IV, MSAT Device provides technical support for Resilience West Chester medical devices, combination products, and their components. This role will partner with internal and external partners for product development efforts, technology and design transfer, and to provide sustained engineering support through post-market surveillance, design changes, investigations, complaints, etc. This role will support site ISO 13485 certification.
· Lead technical aspects of the entire Tech Transfer process for the site from initial evaluation through completion of Process Validation, in compliance with site procedures.
· Define and own technical requirements for new equipment design specifications (URS)
· Develop and own site Control Strategy Documents for processes transferred
· Work with Project Managers to ensure proper planning of MSAT activities to meet timelines.
· Communicate priorities and progress to team on a continuing basis.
· Develop and execute development studies in support of new equipment, products, and processes.
· Make detailed observations, analyze data, and interpret results.
· Ensure proper documentation of activities, actions, and/or results.
· Support creation of documents required for new process execution in Operations, SOPs, Batch Records, Specifications, Initial and ongoing Validation requirements, etc.
· Ensure that Operations has all tools needed to execute new processes in an efficient manner.
· At the point of process transfer to Operations, assure validated state of the process and clear definition and documentation of controls required to maintain validated state.
· Provide leadership, development, and mentoring of Operations colleagues during Tech Transfer and qualification activities.
· Provide support for regulatory inspections as technical process owner
· Coordinate the activities of external resources and other team members as required
· Effectively present technical data in an understandable fashion to support decision making at all levels of the organization.
· Maintain a high level of expertise through review of relevant scientific literature and guidelines and participation at scientific conferences.
· Perform work requirements in a responsible manner in accordance with SOPs, cGMPs and safety procedures in accordance with OSHA requirements and company SHE guidelines.
· Contribute to the development of group and site culture by exercising creativity in dealing with new problems encountered within an evolving organization.
· Take an active role in finding solutions and improvements for the facility as a whole.
· Work independently under the direction of the MS&T Technical Lead.
· Maintain classified area gowning certifications to support assigned tasks, as required.
· Provide support for device risk management activities and collaborate with process engineering and client.
· Support design verification and/or design validation activities during technology and design transfer as required by client(s).
- Direct experience in device / combination product development, manufacturing support, design transfer, or engineering in pharmaceuticals or a similar regulated industry.
- Proven ability to work effectively in a team environment
- Ability to generate and interpret technical documents
- Must have the ability to effectively understand, read, write, communicate, and follow instructions in the English language.
- Ability to lift and handle equipment and materials associated with engineering study execution.
- Minimum 7 years of direct experience and at least 3 years in pharmaceutical or similar regulated industry
- Bachelor’s Degree in engineering or a related discipline
- Prior experience in Technology or Design Transfer in the pharmaceutical industry
- Medical Device and combination product Design Control and Change Management
- Corrective and Preventive Actions in relationship to product design controls
- ISO-13485 Design and Development
- Knowledge of Design Control and Risk Management requirements (e.g., 21 CFR Part 4, Part 820.30, ISO 13485, ISO 14971, EU MDR, etc.), as well as other applicable standards
- High level of knowledge in statistical analysis techniques, test method strategies, development, validation, and risk management methodology.
- Previous experience with automated inspection, assembly, and packaging equipment
- Experience with OEE, TPM, LEAN or other Continuous Improvement systems
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 annualized base pay hiring range for this position is $110,000.00 - $136,250.00. 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.