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Validation Lead

3 months ago

Dublin, Ireland PSC Biotech Ltd Full time
About PSC Biotech

 

 

Who we are?

 

PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

 

 

‘Take your Career to a new Level’

 

PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.

 

  

Employee Value Proposition

 

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



Validation Lead – Fill Finish Facility.

 

Overview:

Validation lead for a large-scale Fill Finish Project in the Pharmaceutical Industry. Lead a team of Validation engineers to ensure the Validation activities associated with a large fill finish project are completed safely, as per schedule and in compliance with GMP and Quality Requirements. 



Requirements

Key Responsibilities:

  • Coordinates and Supervises all Validation activities
  • Approves Validation planning documents detailing overall strategy for the project.
  • Develops and approves the master list of Validation test documents and activities.
  • Reviews and Approves all C&Q summary reports and Validation Summary reports.
  • Ensures the Validation schedule is developed and maintained.
  • Ensures all Validation Engineers who perform Validation activities have relevant training assigned.
  • Pre-Approval and Post approval of Validation test documents.
  • Manages Validation coordination meetings.
  • Responsible for Overall Tracking and Reporting of Validation status and risks/issues.
  • Assist in the development of User Requirement Specifications (URS’s) and Quality Risk Assessment for Equipment and Automated Systems (QRAES)

 

Education / Experience:

  • BS degree with 7+ years of experience in Validation, Engineering, Microbiology or Quality
  • Extensive knowledge and demonstrated experience managing Validation activities for Pharmaceutical / Biotechnology projects
  • Experience of sterile / biotech equipment within the pharmaceutical industry is preferred.
  • Demonstrated strong Communication and Leadership skills.
  • Demonstrated ability to collaborate with senior stakeholders to achieve optimal outcomes.
  • Strong understanding of a risk-based approach to commissioning, qualification and validation within the biotechnology industry
  • In-depth understanding and application of validation principles, concepts, practices, and standards.
  • In-depth knowledge with cGxP as well as regulatory regulations and compliance requirements for Biologics Drug Product manufacturing
  • Working knowledge of sterilization/decontamination systems and industry practices.
  • Experience with AVS (Airflow Visualization) Studies.
  • Experience of aseptic processing.


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