A career with MilliporeSigma is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 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.
The Role: We are looking for a Systems Engineer with a software and hardware background to become a member of a rapidly growing team with a mix of engineers and biologists in our product development team for cell therapy manufacturing equipment. You are responsible for designing, defining, updating, and implementing system requirements, system specifications, input/output processes and working parameters by using current systems engineering methods and technologies. You analyze and coordinate system partitioning (i.e. hardware/software partitioning) and total system integration by using systems engineering practices. You provide expertise and conducts evaluation, validation and verification activities. You document system requirements according to approved procedures and standards. You assist with industry based standards testing for software. You utilize appropriate simulation and analysis tools. You work to ensure efficient and effective transfer of product into production. The candidate must have a desire to utilize their skills to solve complex technical problems in a hands-on manner, working in a fast-paced environment, and across multiple internal and external stakeholders and SMEs.
Who You Are:
- Degree in Systems, Biomedical, Software or equivalent engineering field: Bachelors with 10 years’ experience; Masters with 8 years’ experience; PhD with 5 years’ experience.
- Excellent core engineering skills and relevant industry experience.
- Experience performing multi-discipline, systems-level engineering development.
- Expertise in common engineering development tools for software development and mixed hardware and software systems.
- Experience with Life Sciences industry and with existing regulation (e.g. 21CFR part 11) and validation guidelines (e.g. GAMP5) is preferred; computer validation practices (e.g. CSV) is a plus.
- Familiarity with FDA and EMA requirements for manufacturing equipment and software.
- Strong communications and time management abilities.
- Ability to manage multiple tasks/projects.
- Experience working with CDMOs for research and manufacturing.
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 come2emd.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 his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.