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Process Engineer I
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.
At MilliporeSigma, the Process Engineer works in a dynamic environment supporting the manufacture and testing of high purity filters with a focus on quality, process control/improvements, electro-mechanical assembly, and material handling. The successful candidate will be an enthusiastic team player with high energy and strong engineering skills.
- Maintain efficiency and upkeep of critical manufacturing equipment through effective troubleshooting techniques.
- Identify and improves yield loss and scrap opportunities.
- Develop and recommend new testing processes and technologies to achieve cost-effectiveness and improved product quality.
- Establish operating equipment specifications and improves manufacturing techniques.
- Inspects the performance of machinery, equipment, and tools to verify their efficiency.
- Investigate and initiate corrective action of problems and deficiencies to ensure product quality.
- Develop manufacturing processes that demonstrate levels of statistical control.
- Validate new equipment and process changes.
- Develop and/or implement systems improvement projects and supports maintenance and production groups in resolving technical and engineering issues.
- Provide process on assigned Corrective Action Preventive Action (CAPA).
- Train departmental technicians and operators to ensure sufficient expertise exists within the manufacturing work centers.
- Review capital equipment fabrication activities to ensure manufacturing, construction, installation, and operational testing conform to functional specifications, regulatory safety standards, and user requirements.
- Develop cost estimates, obtains quotes, and generates capital requests to support new processes and capital equipment purchase.
- Lead and participate in Equipment and Process Validation activities per Current Good Manufacturing Practices (cGMP) regulations for Medical Device manufacturing.
- Ensure that product quality features meet product specifications and comply with process validation requirements.
- Generate, review, and approve engineering, manufacturing, and quality procedures necessary to support equipment validation/revalidation, launch, and normal production schedules.
- Facilitate training for individuals involved with the operation and maintenance of processes and equipment introduced to the manufacturing department.
- Generate engineering procedures and review and approves manufacturing standard operating procedures.
- Develop validation protocols and reports in support of cGMP requirements.
- Initiate, review/approve change requests, and develops implementation solutions to support operational needs.
Who You Are:
- Bachelor’s Degree in Electrical, Mechanical, Chemical Engineering or other disciplines
- Master’s Degree in an Engineering discipline or higher
- Experience in an FDA regulated medical device manufacturing facility, pharmaceutical facility, or other regulated industry supporting automated or manual assembly processes
- Instrumentation and PLC/code knowledge
- Lean Six Sigma experience with a green or black belt.
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.