Validation Sr. Engineer - Aseptic Processing

<h2><b>Career Category</b></h2>Engineering<h2></h2><h2><b>Job Description</b></h2><p><b><span>Aseptic Processing Validation Sr. Engineer – Level 5</span></b></p><p><span>The validation department performs sterilisation validation activities to ensure compliance with company procedures and industry standards in support of Operations and Quality Systems for primary and secondary Drug Product Manufacturing.</span></p><p><span>An exciting opportunity has arisen for a Sr. Engineer for the HVAC /AVS (Airflow Visualisation)/APS (Aseptic Process Simulation/media fill) Validation team within the Aseptic Process Validation team.</span></p><p><span>The Aseptic Process Sterilisation team perform /validation/ re-qualification on equipment such as VHP isolators, autoclaves, CIP/SIP systems and Lyophilisers and provide validation oversight on aseptic processing simulations.<br/>This role will focus on managing the team responsible for HVAC requalification in the production environments, including managing the routine re-qualification program of airflow visualisation and filter integrity testing activities as well as testing in response to changes to the production environment.<span>    </span></span></p><p><span> </span></p><p><b><span>The activities of the Aseptic Processing Validation Sr. Engineer</span></b></p><p><span><span>·<span><span>    </span></span></span></span></p><p><span><span>·<span><span>        </span> </span></span></span><span>Support Operations from a Validation perspective to deliver and maintain equipment in a qualified state in the most efficient manner possible. Ensure Validation approach is based on the best available scientific evidence and professional judgment in collaboration with the Validation network.</span></p><p><span><span>·<span><span>        </span> </span></span></span><span>Develop and ensure internal policies, procedures and practices associated with maintenance of the Site Validation Master Plan and Requalification Plans specific to area of responsibility.<span>  </span></span></p><p><span><span>·<span><span>        </span> </span></span></span><span>Responsible for managing and co-ordinating the aseptic process simulation program, including aseptic intervention review, protocol and summary report review, MES hold time support.</span></p><p><span><span>·<span><span>        </span> </span></span></span><span>Responsible for supporting for airflow visualisation studies and HVAC requalification program.</span></p><p><span><span>·<span><span>        </span> </span></span></span><span>Collate and report on relevant validation data and metrics.</span></p><p><span><span>·<span><span>        </span> </span></span></span><span>Provide validation support for Amgen’s quality management system, including change control, deviation and CAPA processes.</span></p><p><span><span>·<span><span>        </span> </span></span></span><span>Participate and deliver regulatory filings and RTQ’s for validation.</span></p><p><span><span>·<span><span>        </span> </span></span></span><span>Provide expert technical validation support to meet site objectives, comprising of the full validation lifecycles process.<span>  </span></span></p><p><span><span>·<span><span>        </span> </span></span></span><span>Work on moderately complex to complex problems, where analysis of situations or data requires in-depth evaluation of various factors. Strong judgment is required in resolving problems and making recommendations.</span></p><p><span><span>·<span><span>        </span> </span></span></span><span>Writes and/or implements, owns and approves changes to controlled documents (e.g., SOPs, Specifications, Master Protocols, etc.) as needed.</span></p><p><span><span>·<span><span>        </span> </span></span></span><span>Support senior leadership in creating and implementing mid to long- term plans for department.</span></p><p><span><span>·<span><span>        </span> </span></span></span><span>Demonstrate ability to successfully interact with other functions on projects that involve negotiation and collaboration with cross-functional peers and more senior management levels.</span></p><p><span><span>·<span><span>     </span></span></span></span><span><span>·<span>   </span></span></span><span>Ensure projects and routine work are executed safely, efficiently, and in accordance with all applicable codes and Amgen Standards.</span></p><p><span><span>·<span>   </span></span></span></p><p><span><span>·<span><span>        </span> </span></span></span><span>Review and approves protocols, reports and data tables generated by staff and contract personnel.</span></p><p><span> </span></p><p><b><span>Basic Qualifications:</span></b></p><p><span><span>·<span><span>        </span> </span></span></span><span>Master’s degree with 5+ years of experience in validation, engineering Or</span></p><p><span><span>·<span><span>        </span> </span></span></span><span>BS degree with 7+ years of experience in Validation, Engineering, Microbiolo