Wallace Myers are recruiting a QUALIFICATION ENGINEER for a contract role based at our Global Biopharma client's site in Waterford.
Contact Jenn Dinan on 014408352
Job title: PERIODIC QUALIFICATION ENGINEER
Location: Waterford
Hybrid with minimum 3 days on-site per week required
About the plant in Waterford
For more than 20 years, our Waterford team has continued to grow and diversify to serve patients around the world. Today, a team of almost 800 work together at a state‑of‑the‑art biopharmaceutical and medical device campus. Recognised through multiple local and national awards, Waterford offers flexible working and access to a world of opportunities to grow your career at one location. As well as attractive benefits, the team enjoy access to an onsite gym and medical centre that underpin a strong commitment to health and wellbeing.
About the job
In the Periodic Qualification Engineering role, you will be required to support the site requalification program. The Periodic Qualification Engineer has a key role in ensuring the on‑going validation and compliance of existing and new equipment, systems and processes at our Waterford plant.
Main responsibilities
Designing, executing and reporting on periodic qualification programme.
Designing, executing and reporting on periodic requalification studies for equipment, systems and processes.
Ensuring periodic qualification 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.
Participation in external regulatory inspections.
Support Site Change Control process.
About you
Experience: 3-5 years' experience working in a Healthcare manufacturing environment - ideally part of which would be in the pharmaceutical sector.
Soft skills
Natural influencer and works well as part of a multifunctional team.
Highly motivated and self‑resilient.
Adaptable and flexible as well as a pragmatically minded problem solver.
Sees projects/tasks through to completion.
Technical 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 requirements for 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 KPIs for the site.
Education
Degree in Science (Chemistry, Microbiology or Pharmacy preferred) or Engineering (Chemical / Mechanical / Electrical).
Languages
English
Benefits
An individual and well‑structured introduction and training when you onboard.
A newly refurbished gym is available onsite.
You will be based in our Waterford site which is accessible from M9.
Parking available onsite.
All applications will be treated with the strictest of confidence.
Contact Jenn Dinan on 014408352
At Wallace Myers International Recruitment Agency we specialise in sourcing professionals for key industries and services. See our website for more details.
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