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Job ID :
66712BR
Location :
US - California - Canoga Park
:
Job Description
When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

The Technical Operations team is responsible for equipment validations, process validations, change control, technical transfer and technical support for RUO and IVD TDX HLA Typing kits and reagents. Validation work includes the ability to perform risk assessments to identify the extent of validation required.

The Scientist III role requires the ability to write protocols, execute studies, and write reports for medium to high complexity equipment and processes. 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 cross functional collaboration during the design control process in order to develop robust manufacturing processes, QC methods, and documentation to support the DMR. The Scientist III will sit on Core Teams where they will develop processes and transfer knowledge to the Manufacturing and QC teams.

In addition, the Scientist III will investigate, drive to root cause, and propose solutions for manufacturing challenges of moderate to high complexity. This position is constantly cross functional in nature and requires independent thought and schedule adherence, under low levels of guidance from the Technical Operations team. The Scientist III also provides guidance to other team members and in many cases, acts as a reviewer and approver of other team members’ work.

Responsibilities:
  • Coordinate and perform validation projects and protocols in support of equipment, method, and process validation of high complexity.
  • Using scientific principles, compliance knowledge, and a risk based approach, develops validation strategies that meet quality and efficiency goals.
  • Write 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 Subject Matter Experts.
  • Recommend approval or failure of validation studies.
  • Train and provide support to Operations to ensure protocols are executed as intended.
  • Maintain knowledge and comprehensive understanding of relevant Medical Device regulations and current interpretations affecting equipment, product and process validation.
  • Act as a mentor to other Technical Operations team members.
  • Act as a resource to other departments for product and process knowledge.
  • Performs root cause analysis and suggest workarounds and/or solutions for recurring issues of high complexity.
  • Adopts 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.
  • Exhibits a high level of quality (right the first time), integrity (do what you say you are going to do), and cross functional behavior (always stay above the line). Embody the Thermo Fisher 4-I Values at all times
  • 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

Minimum Requirements:
  • Bachelor’s degree in Biology, Chemistry, or similar Life Science field
  • 5-7 years of relevant experience in IVD/medical device arena (no product launch or HLA)
  • Consistently demonstrated process validation and IVD design transfer proficiency, with knowledge of equipment qualification (IQ/OQ/PQ), process validation, method validation and computer/automation systems
  • Good analytical skills, with an ability to use scientific knowledge and statistical methods/DOE to identify root causes of process and product failures
  • Demonstrated technical skills in process validation and concepts with an emphasis on implementation
  • Excellent verbal and written communication skills
  • Previous experience in problem solving methodology
  • Possess a continuous process improvement mindset with the ability to effectively lead and manage change.
  • Proficient in use of Microsoft Office Suite and excellent Excel skills
  • Able to work independently, with little guidance from Technical Operations team
  • Some working knowledge of MiniTab/JMP skills
  • Ability to learn new products and technology at a fast speed
  • Hands on knowledge of moderate to complex microbiological lab skills and techniques required
  • Able to successfully lead a project involving a group that may include participants from all levels of the business

Preferred Qualifications:
  • Previous experience in microbiological assay development, protein purification/solid-phase immunochemistry, and PCR techniques
  • Knowledge of HLA
  • Strong project management and organizational skills
  • (PMP)Project Management certification


At Thermo Fisher Scientific, each one of our 50,000 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. Apply today http://jobs.thermofisher.com

Thermo 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.



Thermo 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.
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