Validation Engineer

Key Responsibilities For This Role Include

• Responsible for leading and executing Validation strategies (Validation Plans, Validation Protocols, Validation Reports) for key site Equipment, Systems and Utilities, in line with current regulatory requirements, corporate policies and site procedures
• Ensuring site Qualifications are executed in adherence with Site Validation Master Plan, Validation Plans & SOPs, and presenting executed Qualifications during internal and external audits.
• Ensuring that a continuous state of Validation is maintained for site Equipment, Systems and Utilities, including providing Validation input for site Change Controls
• Responsible for executing site Periodic Review and Revalidation activities for Equipment, Systems and Utilities
• Drafting and executing site Process Validation protocols
• Maintains a contemporary understanding of cGMP regulations and guidance in relation to all aspects of qualification of process and equipment.
• Responsible for leading and executing Validation strategies (Validation Plans, Validation Protocols, Validation Reports) for key site Equipment, Systems and Utilities, in line with current regulatory requirements, corporate policies and site procedures.
• Ensuring site Qualifications are executed in adherence with Site Validation Master Plan, Validation Plans & SOPs, and presenting executed Qualifications during internal and external audits.
• Ensuring that a continuous state of Validation is maintained for site Equipment, Systems and Utilities, including providing Validation input for site Change Controls
• Responsible for executing site Periodic Review and Revalidation activities for Equipment, Systems and Utilities.
• Drafting and executing site Process Validation protocols.
• Maintains a contemporary understanding of cGMP regulations and guidance in relation to all aspects of qualification of process and equipment

The Minimum Qualifications For This Role Are

• 3rd level qualification in a Science/Engineering or related discipline.
• A minimum of three to five years’ experience in a similar role.
• Good knowledge of manufacturing processes is required.
• Knowledge of equipment validation/process validation would be a distinct advantage.
• Good verbal and written communication skills
• Excellent trouble-shooting and problem-solving skills
• Good computer skills (MS Word, Excel and PowerPoint)
• Good attention to detail
• Ability to think logically and be proactive.
• Ability to work as part of a team and on own initiative in a constructive manner
• Flexible and self-motivated
• Can communicate and collaborate much like a native English speaker