What are the responsibilities and job description for the Validation Engineer 2 position at MilliporeSigma?
Work Your Magic with us! Start your next chapter and join MilliporeSigma.
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
Your Role
Validation activities include qualification and re-qualification of facilities, equipment, computer systems, utilities, equipment cleaning, cleanroom qualification, and process validation. Active participation with site projects and multi-disciplinary teams with Manufacturing, Project Management, Process & Analytical Development, Quality Control, Quality Assurance, Packaging, Materials Management, Engineering, and Maintenance to ensure successful implementation and coordination of validation activities. Direct interaction with customers to understand specific validation requirements, ensuring customer needs are met specifically as an API Contract Manufacturing organization: This position is based in St. Louis 3300 South Second Street.
Minimum Qualifications
Apply now and become a part of our diverse team!
If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
Your Role
Validation activities include qualification and re-qualification of facilities, equipment, computer systems, utilities, equipment cleaning, cleanroom qualification, and process validation. Active participation with site projects and multi-disciplinary teams with Manufacturing, Project Management, Process & Analytical Development, Quality Control, Quality Assurance, Packaging, Materials Management, Engineering, and Maintenance to ensure successful implementation and coordination of validation activities. Direct interaction with customers to understand specific validation requirements, ensuring customer needs are met specifically as an API Contract Manufacturing organization: This position is based in St. Louis 3300 South Second Street.
- Provide support to site facilities, utilities, instruments and equipment qualification and process, packaging, computer systems, and cleaning validation
- Prepare, review, and approve documentation for validation and qualification activities to support company, equipment, product and/or performance processes
- Provide guidance and oversee the maintenance of the validated state including requalification/revalidation of equipment and processes
- Read, understand and follow cGMPs, SOPs, Specs, and all guidelines as they relate to the process
- Apply a risk-based approach to operation and interpretation of resulting data
Minimum Qualifications
- High School Diploma or GED
- 5 years of experience within a cGMP environment
- Bachelor’s Degree in a Mechanical, Electrical Engineering or other Engineering discipline OR Chemistry, Biology, or other Life Science discipline
- 2 years of experience within a cGMP environment
- Experience as a team lead; ability to coach, motivating, and occasionally managing a team of peers
- Experience in technical writing
- Mechanical aptitude. Possess critical thinking skills to troubleshoot and commission equipment/processes
- Proficient in Microsoft Office Applications
- Excellent communication skills, both oral and written. Ability to work as part of a team and provide leadership
- Time management skills and the ability to manage oneself. Projects must be completed in a timely manner and per the testing timelines
- Superior attention to detail
- Experience in interaction with regulatory bodies
- Knowledge of API products and CMO
- Ability to liaise with customer and intercept their requirements
- Demonstrated ability to coach develop staff and work effectively will all levels of organization
- Competent in regulations including ISPE, PDA, USP, ICH and US 21CFR Parts 11, 210 and 211
- Complimented with basic project management knowledge
Apply now and become a part of our diverse team!
If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html
