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Application and Validation Scientist
Work Your Magic with us!
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.
This is a field-based role, covering the NE United States. Travel is approximately 50-75%.
- Primarily execute IQ/OQ validation protocols for microbiological testing equipment at customer sites used in the testing of pharmaceutical products or processes: install and prepare equipment and supplies, perform testing, document test results, write reports and maintain records
- Ensure all systems are running according to necessary specifications and operate within regulations to ensure testing of quality products
- Train customers on equipment operation
- Provide PQ consulting to assist customers with test method suitability execution
- Knowledge of application validation regulations and industry standards
- Ability to troubleshoot equipment on-site if needed
- Coordinate with customers and various internal functions to complete validations (customer and technical service, sales, and marketing)
- Partner with the sales team to support the sales process, development of opportunities
- Prepares weekly and monthly reports, plans, and manages workload and budget
- Assist in development of testing protocols
- Travel may be required on short notice, approximately 50-75% of time
Who You Are:
- Bachelor’s Degree in Engineering or Biology with 4+ years lab experience in the pharmaceutical industry
- 4+ years’ experience working with cGMP regulations and documentation requirements
- Ability to develop and execute IQ/OQ validation protocols. Extremely proficient planning and organizational ability, able to coordinate work schedule on short notice
- Ability to develop and execute Feasibility Studies, Method Development and IQ/OQ validation protocols. Extremely proficient planning and organizational ability, able to coordinate work schedule on short notice
- Strong analytical and problem-solving skills; effective writing and verbal communication skills; ability to be a team player/work well alone and with others, ability to multi-task
- Customer-focused, agile, flexible, and adaptable, proactive/action oriented, well developed customer facing skills
- Manages own workload and works with discretion within guidelines. May lead small projects with limited risks and resource requirements
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
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