Validation Engineering Tech

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. 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.
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.
Minimum Qualifications: 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.
Preferred Qualifications: Experience in technical writing.
Strong critical thinking skills to effectively troubleshoot and commission equipment and processes.
Experience interacting with customers or participating in regulatory audits
Experience with Microsoft Office Applications.
Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. We believe that this variation drives excellence and innovation, strengthening our ability to lead in science and technology. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

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