Validation Engineer I - Process Validation at Millipore Corporation in St. Louis, Missouri

Job Description:

Work Location: St. Louis, Missouri
Shift:
Department: LS-SC-POKMA Cherokee STL Technical Operations
Recruiter: Michelle Matthews



This information is for internals only. Please do not share outside of the organization.




Your role:



In the role of Validation Engineer, I - Process Validation, you will be reporting to the Head of MSAT. The Validation Engineer I position is responsible for developing, reviewing, and managing the execution of validation activities.In this role you will provide technical leadership within cross-functional teams with primary responsibility as subject matter expert in the strategy for process validation of unit operations within Bioconjugation and Bio Organics facilities. Job duties and tasks include:

• Define and implement process validation framework.

• Implement consistent process qualification, process validation and continuous process verification (CPV) strategies.

• Define strategy for execution of process performance qualification (PPQ) and product life cycle.

• Generate, review, and approve process validation protocols and reports.

• Lead development of studies around process hold time, homogeneity, mixing etc.

• Lead establishment of drug substance/API manufacturing process control strategies and assess process performance by monitoring and analyzing process/product data.

• Lead process validation related investigations.

• Work closely with the client and personnel from Manufacturing, Process Development, Process Sciences, Quality Control, Quality Assurance, Operations, and Project Management to ensure the scientific and CMC strategies are robust and maintained.

• Maintain compliance with applicable regulatory requirements.

• Data Management, Generation of Process Validation/CPV documents.

• Organizes, manages, and interprets data, performs detailed data analysis.

• Process Validation SME in audits and customer meetings as needed.

• Self-starter with ability to manage workload with minimal supervision.

• Ability to drive projects forward with collaboration and making sound decisions.

Who You Are:




Minimum Qualifications:

• Bachelor's Degree in Engineering (Chemical Engineering, Mechanical Engineering, etc.) or Life Science (Chemistry, Biology, etc.)


• 1+ years of experience in Validation or 1+ year of experience in a GMP Environment.

Preferred Qualifications:

• 2+ years of experience/ SME level of understanding with manufacturing, process validation, Process Performance Qualification (PPQ) and Continued Process Verification (CPV)

• Ability to utilize GDP during document creation and review

• Comfortable in a fast-paced environment with the ability to adjust to changing priorities.

• Flexibility and accountability


• Experience working with current regulatory guidelines and standards.


• Experience working with pharmaceutical standards, rules, and guidance (e.g., FDA, EU, ISO, ISPE, etc.)

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination. Apply Now