Kenny-Whelan are URGENTLY recruiting a contract Validation Engineer for our Pharma Client in Cork
Contact Jenn Dinan on 0214665408
Job SPECification for Validation Engineer
This position will be reporting to the Senior Validation Engineer and will include, but not limited to, the performance of the following duties:
- Write and/or review equipment/facility validation protocols including IT/automated systems (Full Life Cycle).
- Participate in Equipment and IT System Risk Assessments
- Assist in the preparation and/or review of process validation protocol.
- Assist in the preparation and execution of cleaning validation protocols.
- Provide support and documentation required as part of change management activities.
- Organise the review and approval process for validation documentation.
- Examine requirements with respect to Data Integrity/21 CFR part 11 compliance.
- To work in compliance with regulatory requirements FDA, IMB, GxP, Safety and environmental legislation.
- Support Quality programmes
- Interaction and support with project groups
- Assist in the Training of individuals in the execution of validation protocols
Competencies Required to do the Job:
- B.Sc. degree or Engineering Degree
- Knowledge of current cGMP, GMP and FDA regulations
- Minimum of three years validation experience in the pharmaceutical or GMP environment
- Excellent communication and interpersonal skills and an ability to work independently and as part of a team environment
- Knowledge of Equipment validation – the writing and execution of validation protocols including FAT/SAT
- Knowledge of Change Management
- Knowledge of Risk Assessment tools – FMEA, HACCP, Fault Tree Analysis
- Knowledge of Validation of Automation/IT Systems
- An understanding of Data Integrity / 21 CFR part 11 Requirements
- Knowledge of Process Validation
- Knowledge of Cleaning Validation
- Ability to work directly project groups and vendors to ensure compliance with the relevant policies and procedures.
- Ability to schedule/co-ordinate and manage projects through all stages or lifecycle
- Competency is MS Word, MS Excel, MS Access, Lotus Notes
All applications will be treated with the strictest of confidence
To apply or for further information please contact Jenn Dinan on 0214665408 or e-mail with your updated CV to [email protected]