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Manager Validation

Location: 

Bern, CH

Emergent BioSolutions is dedicated to one simple mission—to protect and enhance life. As a global specialty pharmaceutical company, Emergent offers specialized products to healthcare providers and governments to address medical needs and emerging health threats. We value the diversity that each employee brings, and while we look for people who share our Core Values, we thrive on difference as well. With hundreds of talented employees working around the globe, Emergent is a growing organization with a wide variety of scientific, technical and professional career opportunities worldwide.

 

At Emergent BioSolutions Berna, the Swiss affiliate there are - beside manufacturing activities – professionals in Quality Assurance, Quality Control, Supply Chain and Regulatory affairs working.  We are heading to the next period of growth with approx. 130 dedicated and committed professionals working on the Swiss site of Emergent in Bern / Thörishaus.  

 

Emergent is looking to recruit an experienced professional into the role of

 

Manager Validation (f/m)

Position Summary

The role within the Manufacturing, Science and Technology team (MSAT) is responsible for developing a core competency in process-, cleaning- and shipping validation for biotechnological products at late phase clinical trial material production through PPQ campaigns, and commercial production, as well as identifying and leading technical investigations and providing technical advisement to Manufacturing Support Engineers.

This position is responsible for being the primary statistical process control data analyst and supporting technical problem solving for processes entering the commercial production phase of their process lifecycle. This role may have other validation responsibilities as assigned, but will primarily be in charge of validation planning, validation execution support, retrieve process data, analysing of the data, look for positive and adverse trends, correlate the findings, solve issues as noted by the data analysis for process improvement/ refinement, and create written reports about the exercise.

        

Main tasks:

 

  • Perform all functions associated with process-, cleaning- and shipping validation (strategy, planning, writing of plans/ protocols, execution support, reports)
  • Author and lead process risk analysis, critical process parameter and critical quality attributes identification and define control strategy
  • Provide data, analyses, write-ups, reviews, and other input to annual Product Quality Reviews (PQR)
  • Perform process monitoring (control charts) and statistical process analysis including authoring of continuous process verification reports (CPV)
  • Represent Process Validation on global project teams and validation councils
  • Interface with customers technical and Quality representatives
  • Represent Process Validation on internal teams (e.g. Deviation and project meetings)
  • Participate in internal, customer and regulatory inspections
  • Author and support of deviations and change controls in manufacturing
  • Identify potential root causes of process variation and deviations using a systematic approach. Expertise in use for a variety of problem-solving tools e.g. Ishikawa, five-whys, etc. Resolve complex problems and lead multidisciplinary teams in developing and implementing solutions
  • Make recommendations for process changes and sponsor these to the larger process team
  • Actively drive OE and EHS improvements

 

 

 

 

 

 

 

 

Main Requirements

  • Bachelors degree or higher in Life Sciences
  • Highly autonomous and initiative
  • Excellent written (especially technical writing) and verbal communication skills in German and English
  • Experience with mid and large-scale process- and cleaning validation
  • 10y+ experience in GMP regulated Life Science industry (preferably Biotech)
  • Disposable technology experience is a plus

 

 

 

 

 

ABOUT EMERGENT

Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.

Our drive towards this vision informs all of our actions—whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community—we strive every day to achieve this shared goal.

WE BELIEVE IN OUR VALUES

  • Stand shoulder to shoulder no matter what
    • We combine our best thinking and communicate openly to support each other.
  • Break through thinking
    • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
  • Own it always
    • Every person at Emergent is engaged and accountable for delivering on our commitments.
  • Compete where it counts
    • We set the right goals and respect each other as we conquer them together.