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Application and Validation Scientist
A career with MilliporeSigma is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.
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. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology.
We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons.
Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!
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
If you are a resident of Colorado or New York City, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance
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.
As an employee of the Company, you will be required to comply with all of the Company’s COVID-19 safety protocols and policies. The organization has currently suspended enforcement of its COVID-19 Vaccination Policy, but that policy may be reinstated by the Company in its discretion.