Thermo Fisher Scientific-posted 2 months ago
$103,100 - $154,700/Yr
Full-time • Mid Level
West Hills, CA
5,001-10,000 employees
Computer and Electronic Product Manufacturing

When you're part of Thermo Fisher Scientific, you'll do exciting work and be part of a team that values performance, quality, and innovation. As part of a successful, growing global organization, you will be encouraged to perform at your best. Thermo Fisher provides our people the resources and opportunities to make significant contributions to the world. In Validation, every day is different, and with varied day-to-day responsibilities, there is always the opportunity to learn something new, develop your skills in a new area, and meet different people. As the Staff Validation Engineer at the West Hills site, you will oversee continuous improvements in our validation processes, improving efficiency and quality. You will be leading the preparation and execution of validation documentation, including User Requirements Specifications, Installation and Operational Qualification Protocols and Reports, Performance Qualification Protocols and Reports, and Validation Protocols and Reports. We cover validation of equipment, computer systems validation, and process validation, working closely with the site to produce a complete validation package. The Staff Validation Engineer also provides guidance and mentorship to system owners with impact risk assessments to identify the qualification and validation requirements, carrying out validation activities on equipment and processes before returning or handing over to the system owner, and assist in arranging external services when required.

  • Training and advising staff on validation guidelines.
  • Leading multi-functional teams in operations, external contractors, internal multi-functional teams to assist us in completing our validation protocols and reports.
  • Maintaining all documentation (electronic and hardcopy) in line with our quality management system.
  • Ensuring compliance with safety, health, and environment (OSHA) legislation.
  • Developing a compliant and efficient validation strategy for equipment (IOPQs) and process validations for temperature-controlled storage, diagnostic instruments, and production lines.
  • Connecting and communicating with all individuals across the business, relaying information about our benchmarks and ongoing projects.
  • Bachelor or Master's Degree in Chemistry, Biology, Engineering or equivalent.
  • Minimum of 5 years experience in validations, Quality assurance (QA), or engineering within a GMP environment.
  • Shown validation experience in the medical device (ISO 13485), bio-pharmaceutical, or related industry.
  • Experience with developing process improvements for validations of equipment, processes and production lines.
  • Must be legally authorized to work in the United States without sponsorship.
  • Must be able to pass a comprehensive background check, which includes a drug screening.
  • A choice of national medical and dental plans, and a national vision plan, including health incentive programs
  • Employee assistance and family support programs, including commuter benefits and tuition reimbursement
  • At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
  • Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
  • Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
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