Qualification & Validation Specialist

Role Summary:

• A new vacancy has arisen for a Qualification & Validation Specialist to join our client’s Quality Control Projects Team at their busy biopharmaceutical facility in Co. Waterford.
• In this Validation Engineer role, you will be required to support new product introductions, equipment qualification and the site requalification program.
• The Validation Engineer has a key role in ensuring the on-going validation and compliance of existing and new equipment, systems and processes.
• The following activities will be included as part of your role.
• Hybrid option, with up to 40% remote working.

Core Duties and Responsibilities:

• Designing, executing and reporting on PV/Process Performance Qualifications.
• Designing, executing and reporting on validation studies for equipment, systems and processes.
• Ensuring validation studies are managed in conjunction with all required company standards and legal requirements (Health & Safety, cGMP, construction, environmental etc.)
• Providing technical interpretation and guidance of current US FDA and EU validation requirements for aseptic processing, lyophilisation, sterilisation and depyrogenation
• Ensuring that the validation status of equipment and systems are in compliance with cGMP at all times
• Maintaining validation documentation through the validation lifecycle
• Participation in external regulatory inspections
• Support Site Change Control process

Minimum Qualifications and Experience:

• Degree in Science (Chemistry, Micro. or Pharmacy preferred) or Engineering Chemical/Mech/Elec.
• Capable of troubleshooting validation issues associated with projects, process development etc.
• Competent technical knowledge of pharmaceutical plants.
• Previous validation/product development experience would be highly advantageous for the role.
• Knowledge of Process Validation regulations, current process validation and technical transfer industry practices, and experience of interpretation and application of guidelines and regulations.
• Knowledge of requirements for of GAMP, ISPE Baseline guides.
• Knowledge of steam and dry heat validation publications such as AAMI/ANSI, PDA and ISO guidelines.
• Full understanding of relevant quality and compliance regulations
• Able to execute projects to plan.
• Good knowledge of quality management systems.
• Good communication skills at organisation, team and individual levels.
• Ability to use MS Project and SPC packages an advantage
• Understands KPI’s for the site.

Please note, we do not require agency assistance with this role.