Validation Engineer

Role Purpose:

• A fantastic opportunity has arisen for a Validation Specialist. Our client, a state-of-the-art drug substance and drug product manufacturing facility based in Co. Louth, is seeking a Validation Engineer to support their team at the facility.
• The jobholder works within the Global Engineering Team to act as client representative to deliver integrated project engineering services to meet the Project Objectives.
• The Project Engineer will assist in the management of cross functional teams to deliver a portfolio of assigned projects.
• This is a contract position, based fulltime onsite.
• The role may require small periods of travel to support vendor reviews.

Core Duties and 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 & Qualifications Required:

• Bachelor’s degree (or higher) in Biological Sciences/Chemical Engineering/Biological Engineering/Chemistry etc.
• 3-5 years direct experience with a pharmaceutical or biotechnology company with a working knowledge of current regulatory requirements and current Good Manufacturing Practices.
• 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.