Cleaning Validation Engineer

• Industry Pharma/Biotech/Clinical Research
• Work Experience 4-5 years
• City Dundalk
• State/Province Louth
• Country Ireland

PSC Biotech is a leading Biotech Consultancy firm foundedin 1996, headquartered in Pomona, California, USA, with Global operations inIreland, India, Singapore, Australia and the US, serving 350 clients in morethan 23 countries worldwide. We provide cloud-based software solutions forQuality Management and Regulatory Inspections, pharmaceuticals contractmanufacturing professionals, and metrology services to our clients.

PSC Biotech disrupts the conventional consultancy modelby aligning our EVP as one of the unique selling point which includes theopportunity to work with the most talented cohort of like-minded professionalsoperating in the Pharma/ Biotech Industry. We offer a permanent contract ofemployment giving exposure of working in Top Pharmaceutical client sites in adiverse-cultural work setting.

Employees are the “heartbeat” of PSC Biotech, we provideunparalleled empowering career development though Learning & Developmentin-house training mentorship through constant guidance to facilitate careerprogression. We believe in creating high performing teams that can exceed ourclient’s expectations with regards to quality of all scalable and business unitdeliverables, staying under budget and ensuring timelines for our deliverablesare being met.

A fantastic opportunity has arisen for a ValidationSpecialist. The successful candidate will take a lead on utilising the latestinnovations in technology. The role is based at the Drug Substance and DrugProduct Facility in Co. Louth which is a new facility build working to obtainqualification and continued product development. The site is the first facilityin the network focused on manufacturing a live virus vaccine.

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• Support the site validation activities across a number of workstreams.
  
• Develop and maintain the site Validation Master Plan.
  
• Drive development of site cleaning strategy and implement/maintain cleaning and sanitisation protocols and procedures forpharmaceutical equipment, ensuring compliance with regulatory guidelines.
  
• Perform risk assessments to determine the criticality of cleaning processes and set acceptance criteria.
  
• Oversee cleaning validation studies, ensuring proper execution, data collection, and documentation.
  
• Collaborate with production and maintenance teams to establish cleaning procedures and cleaning validation requirements.
  
• Draft, review and approve cleaning validation documentation, reports, and deviation investigations.
  
• Conduct periodic reviews of cleaning validation 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.
  

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• 3-5 years direct experience with a pharmaceutical orbiotechnology company with a working knowledge of current regulatory requirements and current Good Manufacturing Practices.
  
• Bachelor’s degree (or higher) in BiologicalSciences/Chemical Engineering/Biological Engineering/Chemistry etc.
  
• Prior experience in Cleaning Validation, TemperatureMapping 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. xcfaprz
  
• Prior experience in drug substance/drug product, process performance qualification and validation, site readiness and authoring regulatory CTD sections.