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.
Your role: The ideal candidate will have engineering or science related background with a solid understanding of cGMP guidelines as they pertain to the bio-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 raw materials suitable for use in clinical and commercial production applications. 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:
- Design and execute Quality Engineering related protocols; and summarize studies to ensure consistency of data and compliance with manufacturer and customer specifications with current Good Manufacturing Practices.
- Assist in identifying root causes and coordinate corrective action to quality issues in the facility.
- Write risk assessments to assess and identify potential risks associated with various manufacturing and facility activities.
- Drive Operational Excellence and Improvement projects related to Quality.
- Assisting in creating process documentation to ensure production processing consistent within validated parameters.
- Monitor event trends in order to provide proactive corrections/improvement alternatives to minimize the potential for repeat incidents
- Act as technical liaison, as needed, between product development, manufacturing, external manufacturers & suppliers
- Capable of singular project management (within the realm of Quality Engineering) for smaller scope Quality Engineering Plans.
- Issues data, memos, presentations and reports concerning Quality Engineering projects or areas of interest.
- Evaluate equipment or process problems and design testing to determine possible causes or solutions
- Assist in determining process capability of new equipment. Assists in ensuring product development activities have all necessary Quality Engineering supporting justification
Who you are:
- BS in an Engineering or Science related discipline
- 2+ years bio-pharmaceutical, laboratory, manufacturing or Quality Engineering related experience
- 2+ years previous experience in Biopharmaceutical manufacturing facility & quality systems.
- Thorough knowledge of cGMPs and SOPs related to Quality.
- Good working knowledge of associated industry and regulatory guidance documents; FDA guidelines, ISO standards, ASTM standards, etc.
- Excellent knowledge/understanding of protocol acceptance criteria and capable of determining appropriate Corrective action/Preventative Action (CAPA).
- ASQ Certified Quality Engineer, Six Sigma training and Lean Manufacturing training desired
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfill 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.