CSV Engineer III

A career at Resilience is more than just a job its an opportunity to change the future.

Resilience is a technology-focused biomanufacturing company thats changing the way medicine is made. Were 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.

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The CSV Engineer III independently plans executes and leads validation activities across facility utility process cleaning automation and computer systems with deep specialization in automation and computer system validation (CSV). Working within the process team concept the role applies independent technical judgment to resolve complex validation challenges requires no instruction on routine work and partners across engineering quality and operations to keep systems compliant and inspection-ready. As a technical advisor to the validation function it coaches less-experienced team members and builds alignment on validation strategy and approach.

• 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.

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

• Bachelors 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 the need of some flexibility
The work schedule listed reflects the employees 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 $85000.00 - $133750.00 per year. Actual base pay is dependent upon a number of factors including but not limited to the candidates 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.