Wallace Myers are recruiting a Qualification Engineer for a contract role based at our Global Biopharma client's site in Waterford.
About the Waterford plant
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 support the site requalification programme, ensuring ongoing validation and compliance of existing and new equipment, systems and processes at our Waterford plant.
Key responsibilities
Design, execute and report on periodic qualification program.
Design, execute and report on periodic requalification studies for equipment, systems and processes.
Ensure studies are managed in conjunction with all required standards and legal requirements (Health & Safety, cGMP, construction, environmental, etc.).
Provide technical interpretation and guidance of current US FDA and EU validation requirements for aseptic processing, lyophilisation, sterilisation and depyrogenation.
Ensure validation status of equipment and systems remains compliant with cGMP at all times.
Participate in external regulatory inspections.
Support Site Change Control process.
About you
Experience: 3-5 years in a healthcare manufacturing environment – ideally pharmaceuticals.
Soft skills
Natural influencer and works well as part of a multifunctional team.
Highly motivated and self‑resilient.
Adaptable and flexible with a pragmatic problem‑solving mindset.
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 highly advantageous.
Knowledge 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 organisational, team and individual levels.
Ability to use MS Project and SPC packages an advantage.
Understands KPI’s for the site.
Education
Degree in Science (Chemistry, Microbiology or Pharmacy preferred) or Engineering (Chemical/Mechanical/Electrical).
Languages
English.
Benefits
On‑site gym and medical centre.
Parking available onsite.
Access to a newly refurbished gym.
Hybrid work with minimum 3 days onsite per week.
Flexible working and opportunities to grow your career.
Contact
Contact Jenn Dinan.
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