Headcount Solutions Ltd

<< Back

Senior Process Engineer - Dublin

Reference ID : 101MQ
Category :
  • Pharma / Biotech
Date Posted : Nov 14, 2017
Job Location
:
  • Leinster
- Dublin
Experience : 5+ years in a similar role
Salary : Negotiable
Employment Type
:
Contract
Consultant
:
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.



Apply Online

To apply for this opportunity, simply add your details to the form below and upload your CV (in word document format). One of our specialist consultants will contact you to acknowledge your application to discuss the opportunity further.
Your Name *  
Contact Number *  
Email Address *   
Upload CV
 
Additional Notes