A leading pharmaceutical organisation based in Sligo is looking for an experienced Validation Engineer to join their cleanroom expansion project.
- Responsibility for DQ, IQ, OQ, PQ, CV and PV following validation plans and complying with cGMP.
- Drafting of validation protocols and finalisation of reports.
- Maintain site validation procedures and relevant SOP's for shipping, cleaning, and process validation.
- Provide information on relevant regulations and internal validation policy with regards to equipment/instrument, facility, utility, and process validations.
- Verify that validation studies, once complete, have been adequately recorded, documented and carried out, in accordance with the approved validation plan and protocols.
- Provide assistance and ensure the preparation of validation protocols, design specifications and associated documentation for equipment, systems, and processes happens.
- Participate in project teams and assist in determining project schedules and the relevance of appropriate levels of validation.
- At least 3+ years' experience in a GMP environment as a Validation Engineer.
- Experience with validation for sterile environments, equipment/instrument, facility, and utility.
- Familiar with Cleaning Validation and Process Validation.
- Works with the Team and other Departments across the plant to ensure project adherence.
- Excellent english oral and written communication skills, leadership ability and ethical judgment.
- Ability to work collaboratively within a team and with other Departments.
- Ability to work effectively with minimal supervision.
To learn more, apply online or contact Pádraig on +353 87 428 0873 or please submit an updated CV.