A career with us is an ongoing journey of discovery: our 50,000 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.
Who we are: MilliporeSigma is the North American life science brand of Merck KGaA, Darmstadt, Germany – a leading science and technology company. It offers a broad range of innovative products and services to biotech and pharmaceutical drug therapies businesses. Through dedicated collaboration with the scientific and engineering communities, and as one of the top three R&D investors in the life science tools industry, the brand serves as a strategic partner to customers and helps advance the promise of life science.
Your role: The ideal candidate will have engineering or science related background with a solid understanding of cGMP guidelines as they pertain to API pharmaceutical manufacturing, with an emphasis on facility, equipment and process qualification activities.
You will be responsible for managing the technical quality aspects associated with validation and regulatory requirements for the manufacture of clinical and commercial APIs. Areas of emphasis include but are not limited to process validation and capability assessments, facility alarm management (facility temp. pressure, humidity), periodic review of validated systems, trend analysis of facility and utility control data.
Compile and interpret quality data, which includes: process capability studies, trending of system and facility performance and contributing to root cause analysis of deviations. Create and execute Quality Engineering protocols for manufacturing equipment, clean rooms, utilities, and manufacturing processes.
Essential Duties and Responsibilities of this position include but are not limited to:
Who you are:
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.
MilliporeSigma is a division of Merck KGaA, Darmstadt Germany.