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Senior Process Engineer - Dublin

Reference ID : 101MQ
Category :
  • Pharma / Biotech
Date Posted : Nov 21, 2017
Job Location
  • Leinster
- Dublin
Experience : 5+ years in a similar role
Salary : Negotiable
Employment Type
Michael McQuade
Contact Number : 086-0435195
Provide drug product support to process characterization and commercial manufacturing team.

Principal Responsibilities

Senior Process Engineer – Dublin

Our pharmaceutical client in Dublin is seeking a highly motivated individual to function as a member of a commercial drug product team. The successful candidate will report to the Principal Engineer and provide drug product support to process characterization and commercial manufacturing team.

Principal Responsibilities:

  • Position will perform experiments, organize data and analyze results with minimal supervision. 
  • Evaluation of product impact due to process variables will be a critical deliverable for this role. 
  • Understanding of degradation mechanisms for biologics, analytical methods, laboratory practices, and basic statistical methods is a need for this role. 
  • Creation, Management and Maintenance of Inspection defect sets. Execution of Knapp studies and data analysis. 
  • Working to investigate, resolve and closeout all issues relating to NCs, CAPAs, process deviations.
  • The position will establish the experimental design, develop and implement protocols, obtain reproducible and reliable results, and communicate data to the cross functional group. 
  • Cross functional teamwork will be a critical component of this job. 
  • Regular interactions with Quality and Regulatory functions are expectations for this role. 

Qualifications & Requirements

  • Degree in Engineering/Science or equivalent (preferably Chemical Engineering)
  • Significant relevant process engineering industry experience
  • Possess lab experience, inspection experience, inspection qualification, KNAPP Studies.
  • Ideally 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. 
  • Strong knowledge of Quality systems, Drug Product Manufacturing and Validation. 
  • Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion. Excellent communication skills are essential for this role. 
  • Experience in working in a laboratory environment. 

For further information, please contact Mick on 086-0435195 or forward details in confidence below.

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