Qualification & Validation Engineer

4 weeks ago

Waterford, Waterford, Ireland Proclinical Group Full time

Ready for a new engineering challenge within a company that bring life-changing treatments to the world?
Join our client at the forefront of pharmaceutical innovation and make a difference
Proclinical is seeking a Validation Engineer to support new product introductions, equipment qualification, and the site requalification program.
In this role, you will play a key part in ensuring the validation and compliance of equipment, systems, and processes.
This position focuses on maintaining high standards in line with regulatory requirements and company protocols.
Responsibilities:
Design, execute, and report on process performance qualifications (PV) and validation studies for equipment, systems, and processes.
Ensure validation activities comply with health, safety, cGMP, construction, and environmental standards.
Provide technical guidance on US FDA and EU validation requirements, particularly for aseptic processing, lyophilization, sterilization, and depyrogenation.
Maintain validation documentation throughout its lifecycle.
Ensure equipment and systems remain compliant with cGMP standards.
Participate in external regulatory inspections.
Support the site change control process
.
Key Skills and Requirements:
Strong troubleshooting skills for validation issues related to projects and process development.
Knowledge of process validation regulations, technical transfer practices, and interpretation of guidelines.
Familiarity with GAMP, ISPE Baseline guides, and steam/dry heat validation publications (e.g., AAMI-ANSI, PDA, ISO).
Understanding of quality management systems and compliance regulations.
Proficiency in MS Project and SPC packages is an advantage.
Effective communication skills at organizational, team, and individual levels.
Ability to execute projects according to plan and meet KPIs.
Degree in Science (e.g., Chemistry, Microbiology, Pharmacy) or Engineering (e.g., Chemical, Mechanical, Electrical).
Fluency in English
.
If you are having difficulty applying or have any questions, please contact
Dean Fisher
on
******
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe.
Proclinical is acting as an Employment Agency in relation to this vacancy.
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