Process Engineer IV, MSAT
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 Technical has responsibility for leading the planning and execution of all technical aspects of product and/or process technology transfer to the site through successful completion of PPQ. This includes feasibility evaluations, design, execution, and documentation of engineering studies, component specification and evaluation, and all other activities required to support delivery of a complete, validated process to manufacturing. Individuals in this role work closely with Validation, PMO, Supply Chain, Operations, Quality, and technical experts performing transfers to the site to ensure process implementation to commercial manufacturing follows project timelines and corporate standards.
- Key responsibilities
- Lead technical aspects of the entire Tech Transfer process from initial evaluation to PPQ for the site, including change control ownership, 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 (PPQ), 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 primary 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.
- Minimum Requirements
- Significant experience in process development, tech transfer, or engineering, with direct experience 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.
- Willingness and ability to maintain aseptic gowning certification as established by company procedures
- Preferred Requirements
- At least 7 years of experience in process development, tech transfer, or engineering, with at least 3 years in pharmaceuticals or a similar regulated industry.
- Prior experience in Tech Transfer in the pharmaceutical industry, including formulation, sterile filtration, aseptic filling, automated visual inspection, and/or packaging and labeling.
- Previous experience with automated equipment, including recipe creation and process control logic
- 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 base pay hiring range for this position is $110,000.00 - $136,250.00 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.