Applications are invited to apply for this opportunity that exists within the Validation department for the above mentioned position. The successful incumbent will report to the Validation Manager.

Purpose of Position:
To facilitate the validation of equipment (production and laboratory) and utilities on site and to assist in the validation of associated processes.

Requirements:
• Trade apprenticeship, or diploma in electrical / electronic; analytical / chemistry or equivalent qualification.
• 3-5 years Analytical / Production equipment applications experience
• Strong knowledge in the application of Qualification and Validation principles (VMP, DQ, IQ, OQ, PQ, PV, VR, CV)
• CGMP, cGLP, GEP and GAMP
• Knowledge of control and instrumentation systems
• Process and automated packing experience
• Experience in pipe works and ducts
• Repairs and fault finding
• Fault finding and reading electric diagrams
• Familiar with the OSH Act requirements
• Software experience
• Overall knowledge of electrical systems and reading of electrical diagrams

Key Responsibilities:
• Compile and execute the relevant Qualification protocols as per SOP
• Control of Validation Documentation as per SOP
• Evaluate the results from executed validation protocols
• Generate validation reports
• Adhere to change control associated with utilities and equipment
• Assist with Change controls
• Assist with the completion of activities associated with the Validation Plans
• Adhere to Validation practices, policies and procedures
• Adhere to Good Engineering Practices
• Adhere to the Quality Management Systems for Validation documentation
• Assist with review of re-validation Plan
• Prepare and execute re-qualification as per SOP
• Assess and recommend re-qualification of equipment and utilities as appropriate as per Protocol

Key Behavioural Dimensions and skills:
• Detail focused but still with lateral thinking capability
• Well developed planning, problem solving, analytical and communication skills
• Good interactional capability with personnel across function and hierarchy spectrum
• Self management approach
• Ability to work under pressure under conditions with complexities and influences at times beyond immediate self control