Process Engineer II

Resilience; Port Union (OH); On-site; USD 70,000 - 96,000; Full time

Benefits offered by this job

Annual cash bonus

401(k) with company match

Healthcare (medical, dental, vision)

Paid vacation and holidays

Tuition reimbursement

Job summary

Resilience in Ohio is seeking a Process Engineer II to own the technical process for IDAP equipment, drive improvements, and maintain validated state with limited supervision. You will partner with Manufacturing, Quality, Maintenance, and suppliers to deliver projects on time.

The role emphasizes validation, change control, and documentation such as URS, FAT, SAT, IQ/OQ/PQ, along with training and compliance.

Qualifications

• GMP-exposed or regulated manufacturing background with adherence to quality standards.
• Hands-on experience with IDAP technologies and related equipment.
• Baseline proficiency in automation/controls, aseptic/packaging equipment, or validation.
• Ability to work with limited supervision and exercise independent judgment.

Responsibilities

• Owns the technical process for assigned IDAP equipment; defines and maintains centerlines, critical process parameters, material fit for use, and operating procedures to ensure a capable, repeatable process.
• Drives continuous improvement for IDAP processes, including changeover reduction, yield and OEE improvements, maintenance reliability, and waste reduction.
• Tracks equipment data, capabilities, utilization, efficiencies, and obsolescence for assigned assets; manages asset lifecycle and develops user requirements for new asset procurement.
• Provides engineering and project management for assigned projects, including developing project justification, tracking milestones, and informing capital planning.
• Leads validation activities for assigned processes, defining success criteria, confirming process capability, and maintaining validated state through change.
• Authors and reviews URS, FAT, SAT, commissioning, and IQ/OQ/PQ protocols and reports for assigned processes.
• Troubleshoots assigned IDAP processes, diagnosing and resolving equipment and process deviations, including on-call support as required.
• Works directly with equipment and material suppliers on assigned processes to resolve technical issues.
• Identifies, develops, and manages implementation of change controls for assigned processes to improve performance and address root causes.
• Performs and maintains risk management activities for assigned new and existing processes and equipment.
• Initiates deviations and independently leads technical investigations and impact assessments for assigned processes.
• Authors and reviews controlled documents including SOPs, Batch Records, and Rework procedures for assigned processes.
• Supports regulatory inspections as the process owner for assigned IDAP equipment.
• Identifies technical training requirements for Operations, Engineering, and Maintenance for assigned processes, and develops and delivers training materials.

Skills

GMP experience

IDAP technologies familiarity

Automation/controls

Independent work

Education

Bachelor's degree in Engineering or related science

Tools

PLC/SCADA systems

Validation protocols (URS/FAT/SAT/IQ/OQ/PQ)

Job description

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

Brief Job Description

The Process Engineer II owns the technical process for assigned IDAP equipment, working with limited supervision to keep assigned processes capable, compliant, and improving. Drives continuous improvement, validation, and troubleshooting on assigned equipment, and authors the controlled documentation that supports it. Partners with Manufacturing, Quality, Maintenance, and equipment suppliers to resolve technical issues and deliver assigned projects on time.

Job Responsibilities

Process & Equipment Improvement

• Owns the technical process for assigned IDAP equipment; defines and maintains centerlines, critical process parameters, material fit for use, and operating procedures to ensure a capable, repeatable process.
• Drives continuous improvement for assigned IDAP processes, including changeover reduction, yield and OEE improvements, maintenance reliability, and waste reduction.
• Tracks equipment data, capabilities, utilization, efficiencies, and obsolescence for assigned assets; manages asset lifecycle and develops user requirements for new asset procurement.
• Provides engineering and project management for assigned projects, including developing project justification, tracking milestones, and informing capital planning.

Validation & Technical Support

• Leads validation activities for assigned processes, defining success criteria, confirming process capability, and maintaining validated state through change.
• Authors and reviews URS, FAT, SAT, commissioning, and IQ/OQ/PQ protocols and reports for assigned processes.
• Troubleshoots assigned IDAP processes, diagnosing and resolving equipment and process deviations, including on-call support as required.
• Works directly with equipment and material suppliers on assigned processes to resolve technical issues.

Quality Systems & Compliance

• Identifies, develops, and manages implementation of change controls for assigned processes to improve performance and address root causes.
• Performs and maintains risk management activities for assigned new and existing processes and equipment.
• Initiates deviations and independently leads technical investigations and impact assessments for assigned processes.
• Authors and reviews controlled documents including SOPs, Batch Records, and Rework procedures for assigned processes.
• Supports regulatory inspections as the process owner for assigned IDAP equipment.

Training & Development

• Identifies technical training requirements for Operations, Engineering, and Maintenance for assigned processes, and develops and delivers training materials.

Minimum Qualifications

• Prior experience or exposure in a GMP or regulated manufacturing environment, with a demonstrated ability to follow controlled procedures and quality standards.
• Prior training or hands-on experience in one or more IDAP-relevant technologies, such as mechanics, hydraulics, pneumatics, vacuum systems, electronics, PLCs, HMI, computerized systems, vision systems, aseptic/controlled environments, packaging equipment, process or cleaning validation, or change control.
• Baseline proficiency in at least one of the following disciplines: automation/controls, aseptic/packaging equipment, process/materials, maintenance, or validation.
• Ability to work with limited supervision, exercising independent judgment on assigned processes.

Preferred Qualifications

• Bachelor's degree in Engineering or related science, and 2+ years of experience in a GMP or regulated pharmaceutical manufacturing environment.
• Experience with project management and process-improvement methodologies (Six Sigma, Lean).
• Expertise in at least one of the following disciplines: automation/controls, aseptic/packaging equipment, process/materials, maintenance, or validation.

Physical & Work Environment

• Work may involve extended hours, including evenings and weekends, depending on project deadlines and operational needs, as well as occasional travel.
• Physical demands may include prolonged sitting with occasional standing, walking, bending, stooping, twisting, and reaching; the ability to lift or carry up to 20 lbs; infrequent work at heights up to 5 ft; occasional exposure to noise, chemicals, and moving machinery; and the use of personal protective equipment. The role also requires specific visual acuity (including extended computer use, color vision, and depth perception) and the ability to hear and distinguish sounds consistent with interpersonal and group conversation.

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

Work Schedule

8 hours - Monday-Friday

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, including a request to work overtime, 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 $70,000.00 - $96,250.00 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.