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Senior Process Development Engineer
A career with MilliporeSigma is an ongoing journey of discovery: our 58,000 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.
Changes to device manufacturing in the areas of materials of construction, process equipment changes or increasing demand present supply risks to our products used in critical customer applications. Continuous process improvements and updating or introducing new technologies are required to maintain and improve product performance, process robustness, yield and security of supply to our customers. These process improvements must be thorough, reproduceable, sustainable, and effective. Often these changes are required to be made to products that have been used by our customers for long periods of time and performance expectations are firmly established.
The Process and Technology group at MilliporeSigma is responsible for working with manufacturing sites within Operations to identify, lead and execute these changes in order to deliver long term, robust manufacturing processes. The role of the Process Improvement Engineer within the group is to characterize and identify process improvement opportunities and work with R&D, Quality, and the Operations sites to develop and implement process improvements through process changes, the use of new or improved technologies that lead to long term supply security for critical products
The role requires technical creativity and strong initiative and follow-through in executing project responsibilities, overcoming obstacles, and balancing multiple priorities effectively. You will utilize statistical methods to evaluate the capability and reliability of experimental results and to draw meaningful conclusions to inform future actions. You will communicate to colleagues, stakeholders and sponsors though written reports and oral presentations. You must be able to lead multiple complex projects that require technology development, an ability to guide teams, and engage with external collaborators. The idea candidate will:
- Identify gaps in process robustness and product specifications compared to typical customer usage;
- Develop the schedule and required resources for completion of the qualification work;
- Assess the projected cost of the improvement efforts and development and manage the budget for these efforts;
- Work with Product Management and Marketing Operations to determine customer notification requirements for specific changes. Assist Product Management in preparation of customer notification letters;
- Lead preparation of customer summary reports and communicate with customers as needed to convey the results of the qualification work;
- Management overall improvement plan. This includes driving team to meet objectives, schedule and budget;
- Track expenses and resource consumption associated with global material change qualification;
- Evaluate and improve the overall process governing qualification of process or technology improvement and associated customer notification;
- Communicate status, risks and progress of qualification efforts to senior management and key stakeholders.
Who You Are:
- Minimum of Bachelor of Science/Engineering degree with emphasis in materials or chemical or mechanical engineering.
- 10+ years experience in Life Science or related industry
- Ability to travel to Europe at a miniumum of two times per year
- In-depth knowledge of external Quality regulations & standards, including the current ISO 9001, GMP, FDA and EU food contact directives, & other regulations, as applicable
- In-depth knowledge of Quality Systems (Exception, Investigation, CAPA, Risk & Change Management), with experience in establishing, improving, managing & assessing Quality Systems
- At least 5 years experience in process development and improvement including leading risk assessments and FMEA's leading and managing teams
- Ability to work in a matrixed team environment with demonstrated capability to influence and manage w/o authority
- Effective communication skills both at senior management and team levels
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at https://jobs.vibrantm.com
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.