Plant Validation Expert

1 week ago

Waterford, Waterford, Ireland beBeeValidation Full time €60,000 - €80,000
Process Plant Validation Engineer

We are seeking a highly skilled and experienced Process Plant Validation Engineer to join our team in Waterford. As a key member of our operations team, you will play a vital role in ensuring the on-going validation and compliance of new equipment, systems, and processes.


This is an exciting opportunity for a motivated and detail-oriented professional to take ownership of validation activities and ensure that they are managed in accordance with all relevant regulatory requirements, including cGMP, Health & Safety, and environmental regulations.


The ideal candidate will have a strong understanding of process validation principles, protocols, and methodologies, as well as experience with executing FAT/SAT/IOQ protocols and designing, executing, and reporting on validation studies.


Responsibilities:


  • Develop, implement, and manage validation strategies and protocols to ensure compliance with regulatory requirements.
  • Conduct regular audits and assessments to identify areas for improvement and optimize processes.
  • Collaborate with cross-functional teams to develop and implement process improvements and control measures.
  • Analyze and interpret data to identify trends and opportunities for improvement.
  • Provide training and support to colleagues on process validation best practices and regulatory requirements.

Requirements & Qualifications
  • Degree in Science (Chemistry, Micro., or Pharmacy preferred) or Engineering (Chemical/Mech/Elec).
  • Minimum 3-5 years' experience working in a Healthcare manufacturing environment – ideally part of which would be in the pharmaceutical sector.
  • Proven track record of success in process validation and quality assurance.
  • Strong knowledge of cGMP, Health & Safety, and environmental regulations.
  • Ability to work independently and collaboratively as part of a team.
  • Excellent communication and interpersonal skills.

Preferred Qualifications
  • Knowledge of steam and dry heat validation publications such as AAMI/ANSI, PDA, and ISO guidelines.
  • Experience with MS Project and SPC packages.
  • Full understanding of relevant quality and compliance regulations.
  • Able to execute projects to plan.

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