CSV Engineer
- Ireland
- Contract
- Full-time
- Job type:
Automation * Location:
IrelandContae Phort Láirge, ÉirePosting date: 28 Aug 2025Reference: 66817Looking for a new role where engineering meets impact? This CSV Engineer role is calling your name!Proclinical is seeking a CSV Engineer to support the validation and compliance of computerized equipment and systems in a sterile pharmaceutical manufacturing environment. This role involves hands-on validation activities, ensuring adherence to regulatory and quality standards, and collaborating with cross-functional teams to maintain compliance.Responsibilities:
- Develop and execute validation protocols (DQ, IQ, OQ, PQ) for computerized equipment and control systems.
- Generate and review validation documentation, including protocols, reports, and revalidation plans.
- Provide technical expertise on current FDA and EU validation requirements, particularly for lyophilization, aseptic processing, and sterilization.
- Participate in the change control process, advising on CSV-related matters.
- Ensure compliance with cGMP, health, safety, and environmental regulations.
- Troubleshoot validation issues and provide solutions during project execution.
- Review and approve site change controls and ensure validation status aligns with regulatory expectations.
- Collaborate with cross-functional teams to ensure project timelines and quality standards are met.
- Degree in Science (e.g., Chemistry, Microbiology, Pharmacy) or Engineering (e.g., Chemical, Mechanical, Electrical).
- Strong understanding of GAMP, ISPE Baseline Guides, and quality management systems.
- Hands-on experience in validation activities within a healthcare or pharmaceutical manufacturing environment.
- Knowledge of cGMP regulations and compliance requirements.
- Effective communication and facilitation skills across teams and organizational levels.
- Ability to manage projects effectively and meet key performance indicators (KPIs).
- Problem-solving mindset with adaptability and resilience.