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Validation Engineer HVAC
4 months ago
Team Horizon is looking for a Validation Engineer with HVAC qualification experience on a contract basis. You will join a leading biotechnology company based in Dublin.
Why you should consider this opportunity:
- This role offers the chance to be part of a forward-thinking company and work in a cutting-edge facility.
- Competitive rates and flexible working arrangements available.
Key responsibilities:
- Provide technical validation support to meet site objectives throughout the validation lifecycle process.
- Develop, review, and approve validation plans, protocols, and reports related to sterilization validation.
- Support aseptic process simulation, airflow visualization studies, and HVAC requalification.
- Assist in cycle development, performance qualifications, and requalification programs based on project needs.
- Collate and report relevant validation data and metrics.
- Contribute to the enhancement of the validation process and ensure compliance with regulations and standards.
- Support quality management systems including change control, deviation, and CAPA processes.
- Coordinate projects and prioritize tasks in alignment with site goals.
- Participate in multidisciplinary teams as needed and update validation SOPs.
- Engage in regulatory inspections and filings.
- Attend meetings, training sessions, and uphold safety practices within the functional area.
- Operate in accordance with Good Manufacturing Practices and company policies.
Requirements:
- Bachelor of Science/Engineering degree or equivalent with knowledge of cGMPs and regulatory requirements.
- Strong problem-solving skills and effective communication abilities.
- Minimum 3 years' experience in a similar role.
- Experience in equipment qualification and validation processes following ASTM E standards.
- Experience in qualifying sterilization equipment, isolators, HVAC systems, and supporting aseptic process simulation.
- Familiarity with Quality and Document Management Systems such as Trackwise, Maximo, and Kneat.
