Validation Engineer

Posted 23 Dec 2019

Madison, Wisconsin - United States

Req Id 201462

Details

A career with MilliporeSigma is an ongoing journey of discovery: our 56,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. 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.


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, facilities, 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.
  • Provide input on re-validation, assess risk, develop and/or review validation requirements and design deliverables when the facility undergoes changes.
  • 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
  • This role coordinates and provides support and expertise to multiple projects
  • Acts as a 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
  • The Validation Engineer is responsible for the design, schedule, execution, and evaluation of scientifically and statistically sound qualification experiments which define and demonstrate that critical Cleaning, Controls, Equipment, Facilities, Processes and Utilities function in a consistent and repeatable manner, and are in compliance with regulatory requirements, product license restrictions, and policies affecting final product integrity.

 

Who you are:

  • Minimum of 5+ years experience in GMP environment 
  • Bachelor's degree in a science or engineering related field
  • Experience with contractor manufacturing and cGMP API environment highly preferred

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.

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