Job Description

The Stability & Validation Engineer is part of the Cape Town team & Global Quality Validation function which ensures that all equipment, systems, processes and analytical methods are designed and validated in accordance with the applicable rules and regulations. The position requires direct, hands-on skills and involves undertaking activities within all validation projects and working closely with all functions across the global BBI Solutions group network. The position may also involve travel to other BBI sites to conduct specific project activities and/or to attend external customer/business meetings. Role Specific

• Strive to maintain suitable knowledge around Equipment Qualification, Process Validation and verification, cleaning validation, Computer Systems validation, Analytical Method validation, Transport verification and Stability processes.
• Update the site validation plan once validation activity is complete.
• Maintain / update stability plans.
• Contribute to validation project activities within agreed timescales to successfully fulfil all site validation requirements.
• Support the reporting of identified and agreed Key Performance Indicators which control the validation state, (in the absence of the Site Validation Lead).
• Support regulatory, customer and corporate audits as required.
• Experience in working with electronic systems.
• Good understanding of review, analysis, interpretation and management of scientific and technical data.
• Work to ensure the appropriate regulatory records are kept for qualification, validation and stability.
• Ensure timely Reviews of Equipment / Systems are executed in line with the Site Validation Plan master equipment schedule.
• Ensure good communication with the project team and other departments/sites, as appropriate.
• Meet agreed targets for validation or stability project completion as defined within each Project Plan
• Build a thorough knowledge of all validation systems/procedures (and have a degree of understanding around the Design Control process) within the BBI Group Global Quality Management System
• Contribute to the Design Control process on relevant aspects of validation.
• Contribute to the improvement of the BBI Group validation systems/procedures.
• Work closely with the relevant departments, such as R&D, QC, QA and Production, to facilitate all linked transfer and validation requirements.
• Support the site equipment qualification requirements with a xe2x80x98direct, hands-onxe2x80x99 approach.
• Understand Health & Safety regulations relevant to the tasks performed.
• Aim to continuously improve communications and best practice with other BBI departments/sites and customers.
• Contribute to design review meetings when appropriate, (with suitable process and risk knowledge).
• Contribute to project planning and customer meetings, as required.
• Identify and provide solutions for continuous improvement opportunities.
• Maintain accurate and contemporaneous records of all validation and stability work performed.
• Prepare and review data and write technical reports for both internal and external circulation.
• Ensure documentation is written in line with BBI Group Quality Systems
• Be aware of Data Integrity best practices in order to continuously implement best practice.
• Assist the QA Associates with line clearance and batch document review.

Qualifications and Training

• Minimum of a Bachelorxe2x80x99s degree (or equivalent) in a related scientific or engineering discipline.
• Proven talent in the conduct and management of qualification / validation activities and projects.

Knowledge and Experience

• Subject Matter Expertise in one or more validation fields.
• In-depth knowledge and experience in Validation.
• Knowledge and experience in solving complex validation problems and providing guidance to others to solve complex problems.
• Experience desirable in ISO13485, GAMP guides and cGMP with a good understanding of Quality Management Systems.
• Experience in working with electronic systems.
• Good understanding of review, analysis, interpretation, and management of scientific and technical data.
• Related experience in medical devices, cGMP or Active Pharmaceutical Ingredient (API) sectors

Key Skills Required

• High degree of attention to detail and accuracy.
• Strong interpersonal, communication and customer service skills
• Ability to write high-quality procedures, protocols and reports

Job Types: Permanent, Full-time