Staff Validation Engineer (West Hills, CA)

Work Schedule

Environmental Conditions

Job Description

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.

How you will make an impact

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.

Location: West Hills, CA. Relocation assistance is NOT provided. 

What you will do

• 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.

Qualifications:

• 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.

We are looking to engage someone who has the ability to adapt to rapid changes in project priorities and meet challenging deadlines!

At Thermo Fisher Scientific, each one of our 100,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner, and safer.

Compensation and Benefits

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• 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

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards