|Job Ref:||204599752||Employer:||cv-library.co.uk||Industry:||Civil and Structural||Job Type:||Contract||Country:||United Kingdom||City:||Dublin||Address:||Salary:||£45 - £60/hour||Post Date:||30/09/2016 02:22|
Preetha Sampath is recruiting for a Commissioning and Validation Engineer to join a pharmaceutical company based near Dublin, Ireland. This company manufacture a wide range of pharmaceutical products for the human health market and this is a fantastic opportunity to join them on a 12 month contract. The hourly rate on offer for this position is in the region of €45phr - €60phr (Euros). |
As a Commissioning and Validation Engineer, the main purpose of your role will be to provide validation support for all packaging projects on site.
Further responsibilities of this Commissioning and Validation Engineer will be:
• Development of Validation Plans, Installation Qualifications (IQs), Operational Qualifications (OQs), Process Qualifications (PQs), and System Certification Summaries.
• Provide expert technical support in validation to meet objectives of quality, output and cost in projects related to new and existing equipment.
• Prepare, execute, document and report validation protocols in line with GMP's and other regulatory requirements and standards.
• Assure that all validation test procedures are in line with current technology, corporate and governmental regulations.
• Perform IQ, OQ, PQ validation on processes, equipment and systems in conjunction with suppliers as appropriate.
• align with the quality requirements of its customers and applicable regulations FDA, EU & International Standards
• Pre-approve and post-approve validation protocols and assessments from a quality system documentation perspective.
• Assist in the development of a Validation program to ensure continued compliance to the necessary regulations. Preparing Site Automation Validation Guidance Documents
• Collate and report on relevant Validation data/matrices.
• Participate as required in project activities.
• Be aware and adhere to corporate and relevant International Standards and ensure their implementation throughout the plant.
As a Commissioning and Validation Engineer, you will have the following qualifications, skills and experience:
• Bachelor of Science/Engineering degree or equivalent.
• Knowledge of Automation and computer systems, cGMP's and other worldwide regulatory requirements.
• Problem solving ability and excellent oral and written communications skills
• A third level qualification in Science, Engineering or a relevant Quality discipline.
CK Engineers is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference ENG37024 in all correspondence