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 or 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. The following activities will be included as part of your role.

Main responsibilities:
The following activities will be included as part of your role:
* Designing, executing and reporting on periodic qualification program.
* 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 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.

EDUCATION:
Degree in Science (Chemistry, Micro. or Pharmacy preferred) or Engineering Chemical/Mech/Elec)

Languages: English

* 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

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