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Job DescriptionAs part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner, and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.Location/Division Specific InformationThis position will be site based in West Hills, CA and will support our Transplant Diagnostics (TD) business unit of Thermo Fisher Scientific.Discover Impactful Work:The engineering team is accountable for equipment validations, process validations, change control, technical transfer and technical support for RUO and IVD TDX HLA Typing kits and reagents. The application of risk assessment methodology is required for this position in order to support a fast-paced Change Control system while maintaining all IVD compliance, requirements, where applicable. Technical Transfer activities include multi-functional teamwork during the design control process in order to develop robust manufacturing processes, QC methods, and documentation to support the DMR. The validation engineering technician will sit on Core Teams where they will develop processes and transfer knowledge to the Manufacturing and QC teams. In addition, the validation engineering technician will investigate, strive to root cause, and propose solutions for manufacturing challenges of moderate to high complexity. This position is constantly multi-functional in nature and requires independent thought and schedule alignment, under low levels of guidance from the engineering team.A Day in the Life:
Coordinate and perform validation projects and protocols of equipment, method, and process validation of high complexity.
Using scientific principles, compliance knowledge, and a risk-based approach, develop
validation strategies that meet quality and efficiency goals.
Write validation protocols and reports.
Review IQ/OQ/PQ protocols and reports.
Perform and lead Risk Assessment exercises in support of validation activities, and perform periodic reviews as needed.
Collaborate with R&D and Product Development Manager to ensure successful process development and technical transfer to Operations.
Coordinate validation activities in support of assigned validation projects working closely with Quality Systems and Authorities.
Recommend approval or failure of validation studies.
Train and provide support to Operations to ensure protocols are performed as intended.
Maintain knowledge and comprehensive understanding of relevant Medical Device regulations and current interpretations affecting equipment, product and process validation.
Performs root cause analysis and suggest workarounds and/or solutions for recurring issues of high complexity efficiency and implement future state processes.
Embraces PPI as a culture and as way of life and works with Operations & Quality to drive efficiency and implement future state processes.
Participant in our PPI Lean Enterprise initiatives driving improvements through customer delivery & improved quality, as well as cost reduction/avoidance to drive growth and improve profitability.
Provide technical skills for Kaizen events and other Lean initiatives.
Work independently, with little guidance from Technical Operations team.
Keys to Success:Education
Bachelor’s degree required, engineering or Life Science field.
Experience
Minimum 2 years' experience in validations and equipment repair or equivalent experience.
Experience writing and performing validation of equipment (IQ/OQ/PQ), and computer/automation systems.
Knowledge, Skills, Abilities
Excellent Excel skills required.
Ability to learn new products and technology at a fast speed.
Hands on knowledge of moderate to complex microbiological lab skills and techniques preferred.
Able to optimally lead a project involving a group that may include participants from all levels of the business.
Exhibits a high level of quality (right the first time), integrity (do what you say you are going to do), and multi-functional behavior (always stay above the line). Embody the Thermo Fisher 4-I Values at all times.
Good analytical skills, with an ability to use scientific knowledge and statistical
methods/DOE to identify root causes of process and product failures.
Proven technical skills in process validation & concepts with an emphasis on
implementation.
Excellent verbal and written communication skills.
Previous experience in problem solving methodology.
Possess a continuous process improvement mentality with the ability to effectively lead and manage change.
Proficient in use of Microsoft Office Suite.
Performs all job duties in a safe manner, consistent with the Code of Ethics and the Thermo Fisher Scientific 4-I core values of Integrity, Intensity, Innovation, and Involvement.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us (https://jobs.thermofisher.com/global/en/5-reasons-to-work-at-thermo-fisher-scientific) . As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.Apply today! http://jobs.thermofisher.comThermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.Accessibility/Disability AccessJob Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255. Please include your contact information and specific details about your required accommodation to support you during the job application process.This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.Compensation and BenefitsThe salary range estimated for this position based in California is $66,000.00–$99,000.00.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: https://jobs.thermofisher.com/global/en/total-rewardsThermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
