Validation Engineer Trainee - Attach & Train program
Roche · Singapore
Full-time Posted 4 days ago
About this role
<p>At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come
Join Roche, where every voice matters.</p><h3></h3><p></p><h3>The Position</h3><p><b>Purpose:</b></p><p>Maintain the site’s Right to Operate and enable excellence in manufacturing by providing validation support to the production organization that results in safe, high quality, and continuously improving production.</p><p><br />Own, execute and improve the validation lifecycle from Plan to Retire, for manufacturing processes and equipment. This includes, but is not limited to oversight of Equipment, Facility, and Utility Qualification, Cleaning Validation, Shipping Validation in partnership with Distribution, and administration of the Periodic Review and Revalidation Program. Accountable for ensuring compliance with PQS and HA requirements.</p><p><span> </span></p><p><br /><span><b>Key Responsibilities:</b></span></p><p>Support the day-to-day operation of approved Validation SOPs / Plan / Policies for a multi-platform, multi-product, GMP biotech contract manufacturing facility.</p><p>·Develop Validation SOPs, templates, guidelines, Validation Protocols and Reports including supporting site discrepancies and deviations investigation / closure in line with corporate policies and standards.</p><p>· Provide guidance and direction on all validation activities at the Singapore site.</p><p>· Ensure that all validation activities with respect to process, cleaning, facilities/equipment and computerized system stated in validation plan/ protocol are carried out in accordance with relevant policies, standards, procedures and guidelines, and completed in a t
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