Hanley Calibration is seeking a Validation Engineer to join our team supporting a long-standing partnership with a global biopharmaceutical leader. This role involves working on critical capital projects and routine activities within a highly regulated environment, ensuring compliance with GMP and quality standards.
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Provide technical expertise in Controlled Temperature Chambers (CTCs) to meet site objectives.
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Prepare, execute, and document validation protocols and reports in accordance with GMP and regulatory requirements.
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Perform thermal mapping executions for CTCs and manage periodic reviews and requalifications in line with the validation master plan.
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Develop and maintain Standard Operating Procedures (SOPs) to meet site and corporate requirements.
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Assist in creating User Requirement Specifications (URS) and Quality Risk Assessments for equipment and automated systems.
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Participate in cross-functional teams and contribute to investigations and continuous improvement initiatives.
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Ensure compliance with site safety requirements and champion safe working practices.
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Bachelor's degree in Science or Engineering (or equivalent).
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Knowledge of cGMP and regulatory requirements.
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Strong problem-solving skills with excellent written and verbal communication.
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Proficiency in Microsoft Office; experience with Ellab thermal mapping systems and KNEAT software is desirable.
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Previous experience in the pharmaceutical industry is an advantage.
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Work on high-impact projects in collaboration with a world-class biopharmaceutical facility.
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Gain exposure to advanced technologies and industry best practices.
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Competitive salary, benefits, and opportunities for professional development.
Apply today to join a team that has been delivering excellence for over a decade.
