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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.
At MilliporeSigma, the Validation Engineer oversees development and execution of validation protocols and summarization of results into final reports.
- Manage all validation activities for the facility, including planning, scheduling, execution, and project communication.
- Implement projects within budget and schedule.
- Assign resources for projects as required for the expansion, improvement, and modernization of the manufacturing facility.
- Establish timelines and determine resources need to complete protocols.
- Maintain site validation policies and SOPs to meet industry standards and company policies.
- Act as a key member of multi-department teams as the Validation representative bringing new products/processes on-line or troubleshooting and/or improving existing products/processes.
- Review change controls for equipment, utilities and processes and assess any Validation requirements.
- Effectively interact with customers and inspectors and represent the site's Validation program during audits.
- Aid in creation and maintenance and of Standard Operating Procedures and Work Instructions, aligned with ISO 9001 requirements, ICH Q7 requirements and company standards and policies.
- Write and develop procedures independently; execute moderate projects and complex projects with little to no supervision.
- Analyze information, and proposes possible solutions to make independent judgement, recommendations, and decisions.
- Perform other functions and duties that may be assigned by the Quality Manager.
Who You Are:
- Bachelor’s Degree in a Life Science or Engineering discipline.
- 1+ year work experience in a GMP manufacturing facility with demonstrated validation knowledge.
- 3+ years relevant cGMP experience.
- 2+ years of direct validation experience.
- Statistical analysis skills (using excel or other platforms).
- Strong technical and problem-solving skills.
- Strong project management skills.
- Expertise in the principles of validation.
- Ability to multitask and prioritize.
- Understanding of ISO and cGMP quality standards.
- Sound understanding of Quality Risk Management concepts.
- Knowledge of SAP, Trackwise and Microsoft Office.
- Strong organizational skills with the ability to plan and execute multiple tasks.
- Effective written/verbal communication within QC/QA and with cross functional groups; ability to convey any relevant information/potential problems etc. team members.
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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.