Senior Validation Engineer

Desired Skills: validation,operations,manufacturing

The role:

PE Global is currently recruiting for a Senior Validation Engineer on behalf of a leading pharmaceutical company based in Dundalk. This is an initial 11 month contract role.

Description:

The successful candidate will take a lead on utilising the latest innovations in technology.

Responsibilities:

• Support the site validation activities across a number of workstreams.
• Develop and maintain the site Validation Master Plan.
• Drive development of site EMPQ strategy and implement/maintain EM protocols and procedures for graded pharmaceutical areas, ensuring compliance with regulatory guidelines.
  • Perform/involved in risk based EM assessments to determine the environmental monitoring requirements.
  • Oversee EMPQ validation studies, ensuring proper execution, data collection, and documentation.
  • Collaborate with production and quality control teams to establish EM procedures, sampling routines and requirements.
  • Draft, review and approve validation documentation, reports, and deviation investigations.
  • Periodic classification of areas/EM programs to ensure their ongoing effectiveness.
• Support equipment qualification post Operational Qualification (OQ) through to Process Performance Qualification (PPQ) and subsequent revalidation.
• Support global regulatory submissions, internal audits and external inspections/audits as needed.
• Facilitate problem solving & risk assessment projects/meetings.
• Making problems visible and strive for continuous improvement.
• Lead and support various organizational initiatives as needed (examples include safety, financial forecasting, work standardization, etc).
• Keep up to date with scientific and technical developments.
• Maintain continuous focus on quality and safety compliance and unflinching focus on the customer.

Education and Experience:

• 3-5 years direct experience with a pharmaceutical or biotechnology company with a working knowledge of current regulatory requirements and current Good Manufacturing Practices.
• Bachelor’s degree (or higher) in Biological Sciences/Chemical Engineering/Biological Engineering/Chemistry etc.
• Prior experience in Cleaning Validation, Temperature Mapping activities, and qualification of Parts Washers and/or Autoclaves.
• Experience with upstream cell culture and/or downstream formulation/fill finish processes.
• Experience with technology transfer, regulatory filing, and commercial drug substance/drug product manufacturing of biologics.
• Prior experience in drug substance/drug product, process performance qualification and validation, site readiness and authoring regulatory CTD sections.

Interested candidates should submit an updated CV.

Please click the link below to apply, call Kellie on 0214297900 or alternatively send an up to date CV to kellie.hackett@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***