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Validation Engineer IV

National Resilience

National Resilience

west chester, oh, usa
Posted on Wednesday, January 31, 2024

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

Performs, leads and troubleshoots the qualification of facility, utility, process, and cleaning, validation. Specializing in general validation support including all phases of validation.

Job responsibilities:

  • Author, Review and approve documentation needed for qualification of equipment and processes.
  • Serve as an SME to the entire Validation Process: Commissioning, IOQ, PQ, PPQ, CPV
  • Be a Validation Leader in the functional area assigned, Aseptic Activities, Packaging or Inspection
  • Prepare documentation of activities, actions, and/or results.
  • Monitor records to ensure compliance with regulatory requirements.
  • Ensure proper documentation practices during job activities.
  • Answer compliance and process questions from others.
  • Communicate policies and procedures to employees.
  • Gather, organize, and communicate operational information to others.
  • Communicate priorities and progress to team on a continuing basis.
  • Guide others on SOPs (Standard Operating Procedures), control documents, and/or other work instructions.
  • Initiate appropriate action when process deviations occur.
  • Interact with other departments to implement corrective/preventative actions.
  • Participate in cross-functional teams to meet strategic goals.
  • Review and approve change controls, and document revisions.
  • Attend team meetings to discuss progress, initiatives, and/or other matters.
  • Read, understand, and comply with cGMP (Good Manufacturing Practices) and SOPs (Standard Operating Procedures), including general safety, lock outs and so on.
  • Read and interpret diagrams, drawings, and other schematics.
  • Facilitate the execution of validation protocols for processes, equipment.
  • Consult cross-functionally as an SME (Subject Matter Expert) on systems and/or processes within a functional area.
  • Coordinate qualification activities.
  • Participate in troubleshooting activities.
  • Lead process improvement activities and teams to meet strategic goals.
  • Facilitate communication between management and non-management.
  • Investigate deviations.
  • Close out deviations, CAPAs, and/or pAFCAs as needed.
  • Identify temporary and permanent fixes to address issues.
  • Interact with regulatory agency personnel during audits and inspections.
  • Write, review, and revise SOPs (Standard Operating Procedures) and/or work instructions for cGMP (Good Manufacturing Practices) manufacturing of commercial product.
  • Read technical publications and manuals and write associated procedures.
  • Approve new and updated SOPs.
  • Recommend and initiate activities to ensure area and equipment is maintained in a state of compliance.
  • Occasionally Provide "off shift" support (for example: night shift support if you normally work day shift).
  • Assist process engineering and managers with improvement projects.
  • Help Project Managers lead the area of responsibility into timely executions including a risk based validation approach
  • Assist in the training and uplift General Validation knowledge within the group through knowledge sharing.
  • Recommend compliance resolutions to management.
  • Review and approve requirements, specifications, drawings, coding procedures, and guidelines.

Minimum Requirements:

  • Extensive experience in validation or process engineering.
  • Demonstrated experience in a manufacturing or processing setting
  • Ability to expertly read and interpret drawings and diagrams
  • Strong analytical skills, with keen attention to detail
  • Strong communication skills, both written and verbal
  • Demonstrated knowledge of health and safety guidelines
  • Good report writing skills
  • Good problem-solving abilities
  • Ability to prioritize own time and workload
  • Ability to lead multiple activities with concise timelines and troubleshooting practices

Preferred Requirements:

  • Bachelor’s degree in engineering, Computer Science, or a related discipline
  • Experience in a regulated or cGMP environment.
  • Strong knowledge of analytical methodology and instrumentation
  • Strong knowledge of chemical process safety, validation, and quality assurance

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 $95,000.00 - $132,500.00 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.