Thermo Fisher Scientific Managing Scientist, Process Validation in St. Louis, Missouri

Job Description

Managing Scientist, Process Validation

Requisition ID: 67240BR

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.

Location/Division Specific Information

St. Louis, MO

How will you make an impact?

Provide general oversight of an 8–12 member process validation department in a contract manufacturing environment. The success of the site’s Process Validation effort rests on the team and the leadership working for the team. As such, this individual will be accountable to the Global Director of Process Validation (PV)/ Director of Manufacturing Science and Technology (MS&T) for the successful execution of the team’s deliverables. This is largely an office-based role with some but limited interactionwith analytical laboratories and on the manufacturing floor expected on occasion.

What will you do?

  • Implement site and department objectives as detailed by Department Director or higher-level leadership.

  • Oversight of employees will be conducted indirectly through a Supervisor responsible for execution of Stage II validation activities (i.e., manufacturing scale process validation studies according to local policies and procedures), and the direct oversight of data acquisition technicians and Stage III validation engineers.

  • Track multiple projects and use resources to accomplish objectives with quality and on time.

  • Track goals and objectives for the team and the individuals within the team and enable the team members to achieve their own success and the success of the team and therefore the department, our customers, and the St. Louis site.

  • Interface with customers, both internal and external, to solve problems and deliver solutions to problems, executing all interactions professionally, politely, and in the best interests of our customers.

  • Review and approve some process validation documentation. It is likely that minimal authorship duties will occur from time-to-time based on need, but this is not expected to be a regularly recurring function performed by this role.

  • Maintain, create, and update SOPs to ensure that they comply with site, company, and regulatory requirements. Enforce the quality and timely utilization of these SOPs in regard to all work performed by the team.

  • Any other job function assigned by the position’s management as needed.

  • This is not typically a travel-relevant position, but may be required to occasionally travel to other sites or conferences to meet a business need or customer request. Anticipate 5% travel.

How will you get here?

Education

  • Bachelor or Master degree in an Engineering discipline (preferred) or Science (considered based on relevant experience).

Experience

  • 8+ years of overall experience in biologics manufacturing in a commercial facility.

  • 5+ years of experience in the field of validation in a commercial setting (might be commercializing a plant or process that is not yet certified, or this experience could be in fully commercial operations.) Preference will be given in hiring to candidates who have more direct process validation experience over other fields of validation if other qualifications are roughly equivalent.

  • 2+ years of experience as a validation supervisor or validation manager of process or equipment validation in a commercial GMP facility with a record of demonstrable success as a supervisor/manager in this field

Knowledge, Skills, Abilities

  • Ability to work well with a group of employees from varying backgrounds and experience levels and drive a team for successful results.

  • Full knowledge and understanding of ICH Q Documents (all, including current draft documentation); Eudralex requirements for process validation; US FDA requirements and guidance for process validation; current trends in process validation, GMPs, and regulatory expectations within the industry.

At Thermo Fisher Scientific, each one of our 65,000 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.