Sigmar are looking for a Validation Engineer for a biopharmaceutical company known for its qualitative product and innovative process.
The next Validation Engineer will be working in the packaging, for that you will be responsible for ensuring that all validation activities associated with the manufacturing facility follow division quality system requirements and recognised international standards.
• Development of the packaging and inspection validation strategy, validation plans, protocols and reports for all equipment and processes, not limited to FATs/SATs, IV/FTs, risk assessments, IOQ’s, PQ’s etc.
• Ensure all aspects of packaging and inspection validation adhere to required policies and procedures, including safety and training.
• Ensure that the site meets the quality requirements of its customers and applicable regulations FDA, EU & International Standards. Knowledge of ISO 13485.
• Author and execute protocols, reports and assessments from a quality system documentation perspective for primary and secondary packaging, semi-automatic and automatic vision inspection machines and inline/offline leak tester devices
• Update and maintain responsible Standard Operating Procedures (SOP's) in accordance with site and corporate requirements
• Participate, when required, as a member of multidisciplinary site and multisite teams, e.g. Cross functional investigation team.
• Collate and report on relevant validation data/matrices.
• Assist in deviation and exception resolution and root cause analysis.
• Comply with the responsibilities as outlined in the Site Safety Statement and champion safe working practices and initiatives within their functional area
• Perform all tasks with due care and attention and in accordance with Good Manufacturing Practices and requirements, policies and procedures
Qualification and Experience required:
• As a Validation Engineer you must have a third level qualification in Science, Engineering or a relevant Quality discipline. A minimum of 2-3 years ‘experience in a similar position, with automated inspection and/or packaging experience in pharmaceutical or medical devices
• Equipment commissioning experience an advantage along with Validation lifecycle documentation
• Experience with introduction of New Products (NPI’s)
• Problem solving ability and excellent oral and written communications skills
• Honesty and consistency, customer service
• Planning and prioritization, drive for results
• Creative and analytical thinking
• Focus on quality, attention to detail
Are you looking for a new challenge for an important market player? Don’t wait any longer, apply!
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