Process Engineer III, MSAT

Resilience; Kentucky; On-site; USD 80,000 - 121,250; Full time

Benefits offered by this job

Annual bonus

401(k) match

Healthcare

Paid time off

Job summary

Resilience in Ohio is seeking a Process Engineer III, MSAT, to own all technical aspects of technology transfers from feasibility through PPQ and commercial introduction, serving as the primary escalation point for complex process issues. You will coach Process Engineer I/II, partner with Validation, PMO, Supply Chain, Operations and Quality, and lead cross‑functional improvement workstreams.

The role demands GMP experience, MSAT familiarity (PLC, automation, aseptic systems), and a track record

Qualifications

• GMP experience in regulated pharmaceutical manufacturing.
• Experience in MSAT-related areas: PLCs, computerized systems, aseptic environments.
• Ability to coach peers and lead technical troubleshooting.
• Experience managing technology transfer through PPQ.

Responsibilities

• Owns all tech transfer activities from feasibility to PPQ and commercial introduction.
• Lead continuous improvement across processes with DMAIC and risk-based methods.
• Author and approve URS, FAT, SAT, IQ/OQ/PQ protocols and reports.
• Manage projects: justification, resourcing, timelines, and capital input.
• Lead cross-functional manufacturing/quality collaborations and change controls.

Skills

GMP experience

MSAT concepts

Technical troubleshooting

Mentoring/coaching

Education

Bachelor’s degree in engineering or related science

Tools

Automation/Controls

Process validation

Job description

## Process Engineer III, MSATApplylocations: USA - OH - West Chestertime type: Full timeposted on: Posted 3 Days Agojob requisition id: R-107015A 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.comThe Process Engineer III, MSAT independently owns all technical aspects of assigned technology transfers from feasibility through PPQ completion and commercial introduction, serving as the primary technical escalation point for complex process issues. This role coaches Process Engineer I/II staff and partners cross-functionally with Validation, PMO, Supply Chain, Operations, and Quality. # **Job Responsibilities****Technology Transfer & Process Engineering**:* Independently owns all technical aspects of assigned technology transfers from feasibility through PPQ completion, ensuring process capability at each phase gate.* Leads continuous improvement workstreams across multiple assigned processes — including changeover reduction, yield improvement, OEE improvement, maintenance reliability, and waste reduction —, applying structured problem-solving (e.g., DMAIC, RCA) to drive improvements.* Authors and independently approves URS, FAT, SAT, commissioning, and IQ/OQ/PQ protocols and reports for assigned process areas.* Independently manages engineering projects from initiation to completion, including project justification, resourcing, timelines, and capital planning input.* Coordinates and supports Manufacturing/Facility improvement initiatives that define equipment data, capabilities, utilization, and efficiencies; manages the equipment life cycle, including obsolescence planning. **Continuous Improvement & Risk Management:*** Independently leads change control development and implementation, evaluating cross-functional impact and applying risk-based judgment.* Performs and maintains risk management activities for assigned processes and equipment using structured risk assessment tools.* Initiates deviations and leads complex technical investigations across multiple processes, defining CAPAs and assessing impact.* Leads complex technical troubleshooting across multiple assigned processes, developing systematic approaches to recurring issues.**Documentation & Compliance:*** Authors, reviews, and independently approves controlled documents (SOPs, Batch Records, Rework procedures) for assigned process areas.* Authors, reviews, and independently approves validation and change control documents, including master plans, protocols, and summary reports.* Leads validation activities and periodic reviews — including validation required as a result of changes to validated processes, evaluating compliance status and driving corrective actions.**Training & Development:*** Coaches and mentors Process Engineer I and II staff on technology transfer, GMP practices, and problem-solving methodology.* Independently manages external technical relationships with equipment and material suppliers, evaluating solutions and resolving issues.* Designs and delivers technical training programs for Operations, Engineering, and Maintenance.* Serves as key technical contact for regulatory inspections; participates in annual product review and biennial critical systems review.# Education & Experience**Minimum Qualifications:*** Demonstrated GMP experience in a regulated pharmaceutical manufacturing environment, with ability to independently apply controlled procedures and quality standards.* Training or experience in one or more of the following applicable MSAT-relevant technology areas: programmable logic controllers, computerized systems, vision systems, aseptic/controlled environment, formulation, aseptic filling, assembly, packaging, process validation, technology transfer, change control.* Demonstrated proficiency in more than one of the following disciplines: automation/controls, prep, formulation, aseptic filling, assembly, packaging equipment, development and implementation of automated visual inspection tools, technology transfer, or validation.* Demonstrated ability to coach and mentor peers on applicable MSAT processes.* Demonstrated ability to independently lead technical troubleshooting and continuous improvement efforts.**Preferred Qualifications:*** Bachelor’s degree in engineering or related science.* 4+ years of experience in a GMP or regulated pharmaceutical manufacturing or MSAT environment.* Demonstrated project management experience managing technology transfer workstreams through PPQ completion.* Experience with Six Sigma, analytical troubleshooting, or LEAN manufacturing.**Physical & Work Environment*** Work is performed in a combination of office and cGMP manufacturing environments.* Requires gowning and adherence to cleanroom, PPE, and safety requirements.* Occasional lifting of up to 20 lbs; ability to stand, walk, and access equipment on the manufacturing floor.* May require on-call support and occasional work outside standard business hours.*The items described here are representative of those that must be met successfully to perform the essential functions of this job.***Work Schedule**Monday- Friday; dayshift *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.****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.Resilience offers employees a robust total rewards program including 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, paid vacation, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target base pay hiring range for this position is $80,000.00 - $121,250.00 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? We encourage you to apply and start a conversation with one of our recruiters.