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Senior Tech Transfer Engineer

Reference ID : 107MQ
Category :
  • Pharma / Biotech
Date Posted : Jun 19, 2020
Job Location
  • Munster
- Dublin
Experience : Minimum 5 years in a similar role
Salary : Negotiable - DOE
Employment Type
Michael McQuade
Contact Number : 086-0435195
Headcount Engineering is actively seeking to recruit a Senior Technology Transfer Engineer for our client’s biotech facility in Dublin.

Principal Responsibilities

Senior Technology Transfer Engineer

Headcount Engineering is actively seeking to recruit a Senior Technology Transfer Engineer for our client’s biotech facility in Dublin. This role will require the candidate to provide process development support primarily to new product introductions (NPI) and lifecycle management (LCM) changes at the site.

Key Responsibilities 

  • Development of validation plans, process performance qualifications for vial and syringe filling. 
  • Ensuring all aspects of activity within any given process validation adheres to required policies and procedures, including safety and training. 
  • Ensure that the site meets the quality requirements of its customers and applicable regulations (FDA, EU & international standards) with a full understanding of CMC business process related to technology transfer. 
  • Participate in process validation cross functional teams at the site to ensure adherence to required policies and procedures and be responsible to deliver against organizational goals and project milestones. 
  • Pre-approve and post-approve process validation protocols and assessments from a quality system documentation perspective. 
  • Assist in the development of any existing validation program to ensure continued compliance to the necessary regulations and input to site validation guidance documents. 
  • Collate and report on relevant shipping and filter validation. 
  • Assist in deviation and exception resolution and root cause analysis. 
  • Contribute to product quality assessments and process flow documents. 

Qualifications & Requirements

  • Third level Bachelor’s degree in science, engineering or a relevant quality discipline with 5 years’ experience in a similar role OR Master’s degree & 3 years of directly related experience OR Associate’s degree & 10 years of directly related experience. 
  • Must possess 5 years’ experience in a similar role, knowledge of cGMPs and other worldwide regulatory requirement 5 + years of experience in support of Commercial Protein Drug Product (DP) processing in specific areas such as sterile processing, process characterization, tech transfer (to commercial DP sites) or validation is desirable.
  • Strong skills in applying fundamental engineering and scientific principles to the design, implementation and process validation of protein freeze-thawing, filtration, mixing, filling (PpK / batch homogeneity) and/or lyophilisation processes. Knowledge of protein biochemistry with regard to chemical and physical stability. 
  • Project management skills including the ability to manage multiple projects and evaluate project resource requirements. 

For further information please contact Mick on 086-0435195 or forward details in confidence to jobs@headcount.ie

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