Packaging Validation Engineer


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2021-10-19 15:31:081970-01-01Team Horizon
Job TypeContractor
AreaDublinDublinIreland
SectorEngineeringOperations & Manufacturing
Start Date
AdvertiserAshling Guthrie
Job Ref#2219
Job Views259
Description
Due to an Increase in the number of NPI’s and equipment within the Packaging area at our Clients Bulk Drug Substance manufacturing facility, we have an opportunity available for a Packaging Validation Engineer. Reporting to the Validation Lead you willprepare the necessary documentation and monitor progress for technical projects across the organization within the Packaging/Device Assembly Department.  You will also be supporting the execution of the company’s plans and maintaining the company’s position as a knowledge leader in the bio pharma industry.
 
 
Why you should apply:
  • Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work.
  • Competitive rates on offer
What you will be doing:
  • Draft and perform validation testing on product secondary packaging and device assembly equipment.
  • Manage trials on machines or with various processes. Inspect production processes and prepare protocols and summary reports for manufacturing and packaging equipment.
  • Prepare, maintain, or review validation documentation, such as engineering change controls, diagrams, reports or protocols.
  • Review manufacturing processes and perform equipment and process validation studies and recommend process improvements.
  • Review equipment validation periodically to determine it remains within validated state.
  • Conduct validation or qualification tests of new or existing processes, equipment, or software in accordance with internal protocols or external standards.
  • Design Device Assembly studies to support qualification
  • Review validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems.
  • Execute Validation Risk Assessments to determine the level of testing required for new equipment
  • Manage Computer System Validation requirements of various packaging/device assembly equipment
  • Input into the core aspects of Operations, Qualification and Validation SOP's.
  • Provide SME support to closing all validation Records (CAPAs/Change Controls/Deviations)
  • Encourage and sustain a high safety culture and performance within the Validation teams. 
  • Knowledge of Combination Products Regulations
 
 
 
What you need to apply:
  • Technical Degree in Engineering/Life Sciences
  • Relevant experience working in a Validation role in the pharmaceutical industry.
  • Experience of packaging/device assembly equipment and associated qualification.
  • Demonstrated ability to work effectively with various departments and resolve issues in structured manner.
  • Strong technical capabilities, communication skills, teamwork abilities and initiative.
  • Strong knowledge of regulatory requirements and current Health and Safety Regulations legislation.
  • Proven ability to work well as part of a team & on own.
 
 
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