Validation Engineer

Merck•Saint Louis, MO

11d

About The Position

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: In this role you will perform validation activities including 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. Responsibilities include but are not limited to: 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 Develop, review, and approve validation testing and protocols for equipment, cleanrooms, and clean environments in conjunction with other validation team members Work cross-functionally with Manufacturing, Project Management, Quality Control, Quality Assurance, Packaging, Materials Management, Engineering, Information Technology (IT), Operational Technology (OT), and Maintenance Develop, review, and approve equipment/analytical instrument related Engineering Studies Analyze results from Engineering Studies to make conclusions and recommendations. Analyze Design documents for facilities/equipment/analytical instruments Evaluated the impact of proposed changes on the validated state of facilities/equipment/analytical instruments Create validation schedules, coordinate execution efforts with contractors, production operators, production engineers, customers and quality assurance staff members.

Requirements

Bachelor’s Degree in Biomedical Engineering, Chemical Engineering, Biology, Chemistry, or other Engineering or Life Science discipline.
2+ years of engineering experience within a cGMP environment.
1+ years of experience of experience in regulations including ISPE, PDA, USP, ICH and US 21CFR Parts 11, 210 and 211.

Nice To Haves

Experience in technical writing.
Strong attention to detail.
Strong time management skills.
Strong critical thinking skills to effectively troubleshoot and commission equipment and processes.
Excellent communication skills, both oral and written.
Experience reading, understanding, and following cGMPs, SOPs, specifications, and all guidelines.
Experience interacting with customers or participating in regulatory audits
Experience with Microsoft Office Applications.

Responsibilities

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
Develop, review, and approve validation testing and protocols for equipment, cleanrooms, and clean environments in conjunction with other validation team members
Work cross-functionally with Manufacturing, Project Management, Quality Control, Quality Assurance, Packaging, Materials Management, Engineering, Information Technology (IT), Operational Technology (OT), and Maintenance
Develop, review, and approve equipment/analytical instrument related Engineering Studies
Analyze results from Engineering Studies to make conclusions and recommendations.
Analyze Design documents for facilities/equipment/analytical instruments
Evaluated the impact of proposed changes on the validated state of facilities/equipment/analytical instruments
Create validation schedules, coordinate execution efforts with contractors, production operators, production engineers, customers and quality assurance staff members.