Sr. Validation Engineer - NPI Lead

<h2><b>Career Category</b></h2>Engineering<h2></h2><h2><b>Job Description</b></h2><p><b>Validation Sr. Engineer – NPI Lead </b></p><p>The validation department performs 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.</p><p>An exciting opportunity has arisen for a Sr. Validation Engineer to co-ordinate Tech Transfers/ New Product Introductions (NPI) within the Validation team.</p><p>The Validation team at ADL consists of three sub teams – Aseptic Processing Validation, Equipment Validation &amp; Cleaning Validation which together manage the qualification program for the introduction of new products introduction (NPIs) or life cycle modification (LCMs) to existing products. </p><p>The Validation Tech Transfer Lead will lead and co-ordinate NPIs and LCMs for the Validation team and serve as the Validation SME for each new product transferred.  The processes involved may include formulation, filling (vials &amp; syringes), automated inspection and/or assembly and packaging for parenteral products.  The completed validation package will ultimately support the regulatory filings.</p><p><b>The activities of the Validation Sr. Engineer – NPI Lead are to:</b></p><p><span>·   Provide</span> technical input to assess validation impact during initial NPI/LCMs assessment (siting assessment)</p><p><span>·   Project</span> manage and co-ordinate all validation activities for the transfer from line trials, IQ, OQ, PQ and aseptic process simulations (media fills) in conjunction with SME’s.</p><p><span>·   Lead</span> Validation NPI team meetings and define processes for assessment &amp; management of NPIs &amp; LCMs.</p><p><span>·   Develop,</span> review and approve validation plans, protocols, discrepancies summary reports as appropriate</p><p><span>·   Provide</span> support for the execution of cycle development and performance qualifications, as required</p><p><span>·   Support</span> MES/EBR updates that arise as a result of the transfer.</p><p><span>·   Ensure</span> Validation approach is based on the best available scientific evidence and professional judgment in collaboration with the Validation team.  Support a robust fit for purpose transfer with quality designed into the process.</p><p><span>·   Ensure</span> projects are executed safely, efficiently, and in accordance with all applicable codes and Amgen Standards.</p><p><span>·   Assist</span> with trouble shooting the equipment and advise cross-functional team on best qualification strategy. Strong judgment is required in resolving problems and making recommendations.</p><p><span>·   Develop</span> and ensure internal policies, procedures and practices associated with the transfer are in compliance with Validation procedures. </p><p><span>·   Provide</span> validation support for Amgen’s quality management system, including change control, deviation and CAPA processes that arise as a result of the transfer.</p><p><span>·   Support</span> regulatory filings and RTQ’s for validation as required.</p><p><b>Basic Qualifications:</b></p><p><span>·   Master’s</span> degree with 5+ years of experience in Validation, Engineering, Microbiology or Quality</p><p><span>·   BS</span> degree with 7+ years of experience in Validation, Engineering, Microbiology or Quality </p><p><b>Preferred requirements:</b></p><p><span>·   In-depth</span> understanding and application of validation principles, concepts, practices, and standards.</p><p><span>·   In-depth</span> knowledge with cGxP as well as regulatory regulations and compliance requirements for Biologics Drug Product manufacturing</p><p><span>·   Extensive</span> working knowledge of <span>sterilisation/decontamination</span> systems and industry practices.</p><p><span>·   Experience</span> working with critical HVAC systems and qualification of AVS</p><p><span>·   Experience</span> with APS/Media Fill</p><p><span>·   Demonstrate</span> active listening and continuous feedback within team, ability to facilitate problem solving, decision making, and issue resolution</p><p><span>·   Demonstrate</span> ability to successfully interact with other functions on projects that involve negotiation and collaboration with cross-functional peers and more senior management levels.</p><p><span>·   Strong</span> program and change management skills</p><p><span>·   Excellent</span> interpersonal, verbal, and written communication skills are essential in this collaborative work environment</p><p><span>·   Comfortable</span> in a fast-paced, dynamic, and highly fluid company environment with works under consultative direction toward pre-determined long-range goals and objectives.</p><p><span>·   Able</span> to adjust workload based upon changing priorities</p><p><span>·   Previous</span> people management experience highly desired.</p><p><span>·   Able</span> to express ideas and present information eff