Qualification & Validation Engineer

3 weeks ago

Waterford, Waterford, Ireland Eir evo talent Full time

The Role

In the 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.

Job 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 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

Skills

  • 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.

EET7373

If you would like to discuss this role in confidence,contactHarleen Tora/harleen.tora@eirevo.ie

Candidates must be eligible to work full time and long term in the location specified or currently hold a valid appropriate long term work Visa to apply.

eir evo talent, eir evo and our clients are equal opportunity employers who seeks to recruit and appoint the best available person for a job regardless of marital / civil partnership status, sex (including pregnancy), age, religion, belief, race, nationality and ethnic or national origin, colour, sexual orientation or disability. eir evo talent, eir evo and our clients apply all relevant Data Protection laws when processing your Personal Data.

If you choose to apply to this opportunity and share your CV or other personal information with eir evo talent, eir evo and our clients, these details will be held by us in accordance with our privacy policy used by our recruitment team to contact you regarding this or other relevant opportunities at eir evo talent and eir evo

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