CSV Engineer III

Resilience; Port Union (OH); On-site; USD 80,000 - 100,000; Full time

Job summary

Resilience is seeking a Validation Engineer to independently plan and execute validation deliverables for automated and computerized systems. You'll lead activities ensuring compliance with GxP regulations and mentor less-experienced engineers.

Ideal candidates will have a Bachelor's degree in Engineering or related field, with 5+ years in validation. Responsibilities include leading qualification efforts, preparing documentation, and serving as a technical advisor in a cGMP environment.

Qualifications

• Experience in validation or process engineering with hands-on automation.
• Ability to lead validation studies independently.
• Knowledge of GxP regulations and validation standards.

Responsibilities

• Plan and execute validation deliverables for automated systems.
• Lead qualification of GxP computer systems and equipment.
• Prepare and review validation documentation for compliance.

Skills

Validation engineering

Problem-solving

Analytical skills

Communication skills

Attention to detail

Education

Bachelor's degree in Engineering, Computer Science, or related discipline

Tools

Automation platforms (e.g., Rockwell/Allen-Bradley)

Validation lifecycle management software

Job description

Job Responsibilities

• Independently plan, author, and execute validation deliverables - validation plans, protocols (IQ/OQ/PQ), and summary reports - for automation and computerized systems in accordance with GAMP 5 and applicable cGMP requirements.
• Lead the qualification and lifecycle management of automated equipment and GxP computer systems (e.g., PLC, SCADA, DCS), including 21 CFR Part 11 and data integrity (ALCOA+) compliance.
• Serve as a technical advisor on validation strategy and risk-based approach across the facility, utility, process, and cleaning validation portfolio.
• Lead and coordinate validation studies and investigations with minimal supervision, applying independent technical judgment to resolve complex issues.
• Communicate project priorities, risks, and progress to the process team on a continuing basis.
• Identify and drive continuous‑improvement opportunities in validation methodology, automation, and documentation practices.

Documentation & Compliance

• Prepare and review validation documentation, ensuring activities, actions, and results are accurate, complete, and audit‑ready.
• Answer compliance and process questions from cross‑functional partners and serve as a subject‑matter resource during regulatory and internal audits.
• Initiate and document appropriate corrective action when process deviations or system non‑conformances occur, escalating issues beyond established procedures as needed.
• Maintain validated state through change control, periodic review, and requalification activities.

Leadership, Coaching & Mentorship

• Provide technical coaching and guidance to less‑experienced engineers and technicians on validation methodology and automation best practices.
• Build alignment across engineering, quality, and operations on validation requirements and acceptance criteria.
• May oversee and direct the validation activities of others within assigned projects.

Experience & Education

Minimum Qualifications

• Demonstrated experience in validation or process engineering.
• Demonstrated ability to independently lead validation studies and projects from planning through execution with minimal supervision.
• Hands‑on experience with automation and computer system validation (CSV).
• Working knowledge of GxP regulations and validation standards for computerized systems, including 21 CFR Part 11, GAMP 5, and data integrity (ALCOA+) principles.
• Ability to expertly read and interpret engineering drawings, P&IDs, and system diagrams.
• Strong analytical skills with keen attention to detail.
• Strong written and verbal communication skills, including technical report writing.
• Strong problem‑solving abilities and sound independent judgment.
• Ability to prioritize and manage own time and workload across concurrent projects.
• Ability to coach peers and provide technical guidance to less‑experienced team members.

Preferred Qualifications

• Bachelor's degree in Engineering, Computer Science, or a related discipline.
• 5+ years of experience in validation or process engineering, including hands‑on automation and computer system validation.
• Experience in a regulated or cGMP manufacturing environment.
• Familiarity with structured software development lifecycle (SDLC), configuration management, and scripting for automated and computerized systems.
• Hands‑on experience with industrial automation platforms (e.g., Rockwell/Allen‑Bradley, Siemens, or Emerson DeltaV PLC/SCADA/DCS) and data historians.
• Familiarity with automated testing tools and validation lifecycle management (VLM) software.

Physical & Work Environment

• Work is performed in a combination of office, laboratory, and cGMP manufacturing environments.
• May require gowning and adherence to cleanroom, PPE, and safety requirements.
• Occasional lifting of up to 25 lbs and the ability to stand, walk, and access equipment on the manufacturing floor for extended periods.
• May require work outside standard business hours to support production schedules, shutdowns, or time‑sensitive validation activities.

Work Schedule

8 hours - Monday-Friday with some flexibility.

Schedule may be modified at any time. 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.