Staff Validation Engineer (West Hills, CA)
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Job Location:
West Hills, CA - USA
Monthly Salary:
$ 103100 - 154700
Posted on:
30 days ago
Vacancies:
1 Vacancy
Job Summary
Work Schedule
Standard (Mon-Fri)Environmental Conditions
Cold Room/Freezers -22degreesF/-6degrees C Laboratory Setting Loud Noises (Equipment/Machinery) Office Some degree of PPE (Personal Protective Equipment) required (safety glasses gowning gloves lab coat ear plugs etc.) Will work with hazardous/toxic materialsJob Description
When youre part of Thermo Fisher Scientific youll 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.
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 Masters 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 Stateswithoutsponsorship.
Must be able to pass a comprehensive background check whichincludes 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 100000 extraordinary minds has a unique story to tell. Join us and contribute to our singular missionenabling our customers to make the world healthier cleaner and safer.
Compensation and Benefits
The salary range estimated for this position based in California is $103100.00$154700.00.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: Experience:
Staff IC
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more
