Senior Process Engineer (Tech Transfer)

I8053

DPS Engineering are recruiting for a Senior Process Engineer with Tech Transfer experience for one of our Pharmaceutical clients based in South Dublin. 

Category:
Engineer Chemical
Location:
Leinster
Years of Experience Req.:
5 Years+
Date Posted:
22/11/2021
Days Remaining:
183
Employment Type:
Contract
Education Level Req.:
Third level Degree (Level 8)

Senior Process Engineer (Tech Transfer)

DPS Engineering are recruiting for a Senior Process Engineer with Tech Transfer experience for one of our Pharmaceutical clients based in South Dublin. 

Role & 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 organiz525331.586055ational goals and project milestones.
  • Pre-approve and post-approve process validation protocols and assessments from a quality system documentation perspective.
  • Actively communicates across functions and sites and is a strong collaborator with all the functional groups at the receiving site, sending site and corporate functions.
  • Act as the responsible point contact from ADL site for the transfer project for drug product teams and Global Operations Teams.
  • 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:

  • Third level Bachelor’s degree in science, engineering or a relevant quality discipline
  • 5 years technical transfer experience. Drug product preferred but not essential, Drug Substance will be considered
  •  cGMP experience and knowledge of other worldwide regulatory requirements.
  • Candidates will need to be able to explain their experience in bringing in processes or products into a manufacturing facility
  • Strong understanding of process validation, from characterisation, development characterisation and formal validation
  • Experience in formulation and lyophilisation an advantage

 
 

DPS is an Equal Opportunities Employer.

Recruitment Agencies: Please do not reply to this job advert.

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