Senior Validation Engineer

About PSC Biotech

• An exciting opportunity has opened in the **** validation team for a Validation Engineer.
  
• In this role you will be responsible for delivering on the qualification and validation program at *** which will include planning and execution of sterilisation validation / requalification activities on critical sterilisation/decontamination equipment.
  
• The sterilisation team perform /validation/ requalification on equipment such as VHP isolators autoclaves CIP/SIP systems and Lyophilisers and provide validation oversight on aseptic processing simulations.
  

• Provide technical validation support to meet site objectives comprising of the full validation lifecycle process.
  
• Develop review and approve validation plans protocols discrepancies summary reports in the area of sterilization validation.
  
• Provide support for the aseptic process simulation program including aseptic intervention review protocol generation execution and summary report generation.
  
• Provide support for airflow visualisation studies and HVAC requalification program.
  
• Provide support for the execution of cycle development performance qualifications and requalification program in line with projects and site validation masterplans.
  
• Collate and report on relevant validation data and metrics.
  
• Assist in the development and improvements of the validation lifecycle process while ensuring continued compliance to all applicable regulations and *** standards. In addition provide input and guidance into multisite and local procedural requirements.
  
• Provide validation support for**** quality management system including change control deviation and CAPA processes.
  
• Coordinate projects and prioritize workload in line with site priorities.
  
• Participate when required as a member of multidisciplinary site and multisite teams e.g. cross functional investigation teams and change control.
  
• Update and maintain validation Standard Operating Procedures (SOPs) in accordance with site and corporate requirements.
  
• Participate in regulatory inspections regulatory filings.
  
• Attend and contribute to staff meetings and attend appropriate training sessions as required.
  
• Comply with the responsibilities as outlined in the Site Safety Statement and champion safe working practices and initiatives within their functional area.
  
• Perform all tasks with due care and attention and in accordance with Good Manufacturing Practices and *** requirements policies and procedures.
  

Requirements

• Bachelor of Science/Engineering degree or equivalent.
  
• Knowledge of cGMP s and other worldwide regulatory requirements.
  
• Problem solving ability and excellent oral and written communications skills
  
• 3 years experience in a similar role
  

• Experience in equipment qualification and the validation lifecycle process in line with ASTM E2500.
  
• Experience qualifying sterilisation equipment isolators HVAC systems and/or providing validation support for aseptic process simulation.
  
• Experience of Quality and Document Management Systems including Trackwise Deviations CAPA and Change Controls Maximo CDOCs Kneat.
  
• Independent selfmotivated proactive organized able to multitask in project environments and skilled in communication and collaboration.
  
• Team player prepared to work in and embrace a teambased culture that relies on collaboration for effective decisionmaking.