Thermo Fisher Scientific Process Validation Associate I in St. Louis, Missouri

Job Description

Process Validation Engineer 1

Requisition ID: 68744BR

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?

The Process Validation Associate 1 is responsible for assisting more senior process validation scientists and engineers (when they are functioning as study directors) with execution of process validation studies. This role is primarily focused on the acquisition and delivery of data to the CPV team for analysis and on assisting the execution of manufacturing scale PV studies and the acquisition and delivery of data related to those studies.

This role is a growth role at the entry level and the career path of an individual moving into this role will be to obtain an understanding of process validation means and methodologies, requirements, and policies and procedures and their implementation at Patheon Biologics before moving into Process Validation Engineering/ Scientist roles. On a daily basis, this position obtains instruction from the CPV engineers on what data must be gathered and delivered, and then obtains and delivers that data. Secondarily, this role will obtain other direction from the Process Validation manager in regard to assisting other members of the PV team with study execution and/ or study data gathering and delivery.

What will you do?

  • Discrepancies: Able to assist on process validation discrepancies or investigations with substantial oversight and direction from more senior members of the staff.

  • Deviations: Able to provide input to deviation investigations in the form of data and data verification.

  • Change Controls: Not anticipated to participate in the change control process unless directed by and with the oversight of more senior staff members. It is expected that this position will learn the change control system while functioning in this role to be able to participate in it as career progression begins.

  • CAPA: Not anticipated to participate in the CAPA process unless directed by and with the oversight of more senior staff members. It is expected that this position will learn the change control system while functioning in this role to be able to participate in it as career progression begins

  • Observations: Not anticipated to participate in the change control process unless directed by and with the oversight of more senior staff members.

  • SOPs: May create and/or modify SOPs related to job role with significant oversight and direction.

  • APR/ BLA Generation / Review: May provide data to others for inclusion in APR and BLA.

  • Is not expected to participate in internal or joint project teams, but may participate on an ad hoc basis when required.

  • Training / cGMP’s / Regulatory: Follows all training and policy guidelines and standard operating procedures established for the facility and business unit as well as all cGMP requirements. Ensures employee training profile is up to date at all times and completes all training on time.

How will you get here?

Education & Experience

  • Bachelor’s degree in a Scientific (non-engineering) with a verifiable work history.

  • Must be able to fulfill all gowning requirements to enter controlled spaces and function safely on the operations floor

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.