Qualification & Validation Engineer
- Ireland
- Contract
- Full-time
- Job type:
Validation * Location:
IrelandWaterford, Republic of IrelandPosting date: 30 Jul 2025Reference: 66491Ready 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.
- 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.