The Computer System Validation (CSV) Engineer is primarily responsible for driving GxP validation lifecycle management activities for computerized laboratory systems and equipment, ensuring that all activities are completed and documented in accordance with cGMPs that fulfill relevant federal regulations and standards.
The CSV Engineer is responsible for the following:
- Driving validation and equipment qualification activities
- Authoring/revising validation deliverables, (e.g. risk assessments, failure mode effect analysis, system design configuration documentation, validation summary reports)
- Facilitating all verification and validation activities with system owners and IT, (e.g. user and system design requirements, trace matrices, installation, operation and performance protocols)
- Introduce process improvement methodologies for CSV
- Provide training to other team members relative to GxP validation principles.
- Supporting Data Integrity requirements
- A minimum of 5 years of experience working within an FDA regulated (Medical Device or Pharma) industry required.
- Demonstrated knowledge of 21 CFR Part 11, including ERES, and predicate rule requirements.
- Demonstrated experience in the validation of all computer system categories: automation control, laboratory systems, quality workflow, ERP, clinical, preferred
- Working knowledge of implementing GAMP 5 guidelines that achieves compliant computerized systems for intended use
- Working knowledge of ISO13485, ISO9001, PIC/s of FDA regulated manufacturing processes
- Experience in authoring validation documents and executing protocols for equipment used in GMP production. .
- Highly proficient with GAMP 5 principles and risk-based approach to computer system validation in GxP environment.
- Demonstrated knowledge of a broad set of improvement and statistical tools/methods used within process excellence activities.
- Demonstrated organizational, interpersonal, oral and written skills.
- Demonstrated ability to lead or facilitate projects using quality improvement measures, (e.g., DMAIC/Lean methodologies) from inception through implementation of recommendations and solutions.
- Proven ability to drive and develop improvement of critical business metrics.
- Collaborate and assist all departments with equipment validations to achieve and maintain company-wide regulatory compliance and operational efficiency.
- Ensure quality of process and product as defined in the appropriate operation and material specifications.
- Will assist in the selection of components and equipment based on intent of use, analysis of specifications, reliability and regulatory requirements.
- Will analyze equipment to establish operating data,
- Work to introduce and implement process improvement, statistical and problem-solving tools and methodologies.
- Provide training for team members relative to CSV compliance requirements.
- Ensure adherence to GMP and safety procedures.
- Bachelor's degree in computer science, engineering, or similar field required.
- Employee may be required to lift routine office supplies and use standard office equipment.
- Ability to stand or sit for extended periods of time.
- Majority of work is performed in a desk/cubicle environment, but at times, may have exposure to high noise levels in the various areas, (e.g., laboratory, warehouse)
- This position requires periodic travel and some evenings, weekends and/or Holidays.
This job description reflects management’s assignment of essential functions. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
Caris Life Sciences is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability or genetic information, or any other protected characteristic as outlined by federal, state, or local laws