Senior Validation Engineer

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

About PSC Biotech

Who are we?

PSC Biotech is a leading Biotech Consultancy firm foundedin 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in morethan 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 modelby 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 adiverse-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 ourclient’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.

Overview:

Looking for senior Validation Engineer with team lead experience reporting to the Commissioning Qualification and Validation Manager,day to day technical direction may be delegated to the Engineering Validation Team Lead as required, and is responsible for fulfilling validation activities in a GxP regulated environment,including implementation of laboratory systems, newmanufacturingequipment/processesandchangestoexisting equipment/processes.

Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugsfor the commercial market. These individuals build and maintain cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goodsand services to support manufacturing and coordinating the worldwide movement of our drugs to patients.

Responsibilities:

• In collaboration with plant support functions, assist with planning, set up and implementation of Analytical Instrument Qualification, Facilities, Utilities, Equipment (FUE) Qualification and Process Validation programs.
• Execute (protocol generation, execution, and final package preparation) Validation activities related to the various Validation disciplines e.g. FUE Qualification, CSV, New Product Introductions and Change Control.
• Develop validation plans for specific system implementation projects.
• Support the establishment of site validation policies,through development, generation and implementation of site validation masterplans, guideline documents and standard operating procedures.
• Prepare and track to completion any assigned change requests, deviations, quality events and associated CAPAs.
• Develop and demonstrate an active approach to safety,industrial hygiene, environmental and regulatory compliance.
• Assistwithpreparationofregulatoryfilings and participation during regulatory inspections/partner audits.
• Maintain current knowledge of industry standards and regulatory requirements for products developed or manufactured, validation techniques/approaches and systems utilized
• Lead and represent validation in multi-departmental meetings and project teams.
• Identifies and implements improvements to the Engineering Validation systems.
• Coordinatevalidationactivitiesinvolvingcross-functional, multi-departmental teams including:
  
  Manufacturing,Process Sciences, Process Development, Quality Control, Quality Assurance,Regulatory Affairs, and others.
• Drug Product-specific. Drug Product experience is still apreference but we will look at other validation experience as well (e.g.Cleaning, Steam, Temperature Mapping).