Validation Engineer (NPI)

2022-07-13 09:30:262049-12-30Team Horizon
Job TypeContractor
LocationSligo
AreaSligoSligoIrelandSligo
SectorQuality
Start Date
AdvertiserDarcy Ainscough-Denton
Telephone+353 1 574 6266
Job Ref2539
Job Views61
Description
Validation Engineer – Team Horizon
 
Team Horizon currently has an exciting opening for Validation Engineers for our client who are a global leader in the Biopharmaceutical Industry. This role will support our client’s New Product Introduction, which is projected to close out in 2025. This role will be crucial in identifying systems and processes requiring validation/quality assurance support ensuring that those activities are documented, actioned, and resolved in a timely fashion. 
This role will involve close contact with personnel within the plant at all levels and with internal and external auditors, e.g. FDA, HPRA. You will also interact with other sites and TPM personnel in cross-functional activities.
 
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.
  • The role is generously compensated and attracts a competitive salary.
  • Opportunity to work on exciting projects.
 
 
What you will bedoing:
  • Active participation in the site Validation Program and general Quality Assurance activities.
  • Coordination / direction and active participation in the validation and qualification of site equipment, utilities, processes and software in compliance with company policies, FDA, European cGMP and GAMP standards.
  • Generation/maintenance/execution of Project Validation Plans and schedules.
  • Generation of validation protocols and final reports to cGMP standards.
  • QA support for validation investigations and implementation of corrective actions.
  • Creation/Review/Approval of various validation and qualification documents
  • Management of validation, exception event, and change control processes.
  • Documenting all activities in line with cGMP requirements.
  • Performing cross training within the team and training of new team members.
  • Participation in continuous improvement programs to implement improvements in manufacturing, quality, safety and training systems.
  • Coordinating activities to maximize the effectiveness of all of the team members.
  • Communicating with peers and management regarding activities in the area, including elevation of events or concerns.
 
What you need to apply:
  • A minimum of 3 years’ experience in a cGMP regulated environment.
  • 3years plus validation/Quality experience in sterile/aseptic environment especially in the commissioning and qualification area
  • 3 years plus of knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry
  • Strong communication (written and oral), presentation and troubleshooting skills required
  • Effective interpersonal and organizational skills.
  • Ability to work well both independently and in a team environment.
  • Capable of prioritizing work and multitasking.
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Darcy Ainscough-Denton
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