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Validation Engineer, Membrane Facility Lead
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 role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
The Membrane Facility Lead Validation Engineer at MilliporeSigma will lead all validation activities and will provide stewardship for the validation of new equipment and instrumentation for the new facility by developing, influencing, and overseeing work related to customer and internal analytical validation requirements regarding membranes.
- Coordinates validation strategy for the new K3 Lateral Flow membrane facility
- Builds VMPs
- Coordinates with Equipment Engineering team to support drafting IQ/OQ/PQ validation protocols/reports
- Works with Engineering on C&Q documentation, execution, and approval of C&Q protocols/ reports; establishes C&Q RACI matrix
- Leads the validation of quality methods, procedures, and processes
- Leads validation projects on instrument qualification
- Designs experimental plans to validate analytical methodology and instrumentation according to customer and/or internal policy, supports monitors and reports actualization of the plan, completing all necessary documentation required to realize the maximum value of the resulting information
- Prepares Design of Experiment (DOE)’s if required, including hypothesis, scope, materials, experimental design, timeline, procedure, results/discussion and conclusion sections
- Requests necessary resources and supports project team development, which could include analysts, metrologists, production staff and project managers, including those from other departments
- Reports study results within MilliporeSigma and to suppliers and customers via e-mail communication and presentations
- Establishes new control charts, including selection and validation of monitor parameters
Who You Are:
- Bachelor's degree in Chemistry, Chemical Engineering, or other Life Science
- Master’s Degree in Chemistry, Chemical Engineering, or other Life Science OR Master of Business Administration
- 3+ years of validation experience
- Strong technical background to interpret complex data
- Experience with Microsoft Office and Statistical Software (JMP)
- Problem-solving skills and organizational ability
- Project Management skills
- Knowledge of SAP and LIMS
- Good oral and written communication skills
- Experience with ISO 9001; ISO 14001, ISO 13845
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!
Curious? Chat with one of our curious minds on our interactive Q&A platform and catch a glimpse of our people, values, and culture. You can also apply and find more information at https://jobs.vibrantm.com
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 NYC, Connecticut or Colorado, 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.