Sr. Validation Engineer - NPI Lead

Career Category

Job Description

Validation Sr. Engineer – NPI Lead

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.

An exciting opportunity has arisen for a Sr. Validation Engineer to co-ordinate Tech Transfers/ New Product Introductions (NPI) within the Validation team.

The Validation team at ADL consists of three sub teams – Aseptic Processing Validation, Equipment Validation & Cleaning Validation which together manage the qualification program for the introduction of new products introduction (NPIs) or life cycle modification (LCMs) to existing products. 

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 & syringes), automated inspection and/or assembly and packaging for parenteral products.  The completed validation package will ultimately support the regulatory filings.

The activities of the Validation Sr. Engineer – NPI Lead are to:

·   Provide technical input to assess validation impact during initial NPI/LCMs assessment (siting assessment)

·   Project 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.

·   Lead Validation NPI team meetings and define processes for assessment & management of NPIs & LCMs.

·   Develop, review and approve validation plans, protocols, discrepancies summary reports as appropriate

·   Provide support for the execution of cycle development and performance qualifications, as required

·   Support MES/EBR updates that arise as a result of the transfer.

·   Ensure 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.

·   Ensure projects are executed safely, efficiently, and in accordance with all applicable codes and Amgen Standards.

·   Assist with trouble shooting the equipment and advise cross-functional team on best qualification strategy. Strong judgment is required in resolving problems and making recommendations.

·   Develop and ensure internal policies, procedures and practices associated with the transfer are in compliance with Validation procedures. 

·   Provide validation support for Amgen’s quality management system, including change control, deviation and CAPA processes that arise as a result of the transfer.

·   Support regulatory filings and RTQ’s for validation as required.

Basic Qualifications:

·   Master’s degree with 5+ years of experience in Validation, Engineering, Microbiology or Quality

·   BS degree with 7+ years of experience in Validation, Engineering, Microbiology or Quality 

Preferred requirements:

·   In-depth understanding and application of validation principles, concepts, practices, and standards.

·   In-depth knowledge with cGxP as well as regulatory regulations and compliance requirements for Biologics Drug Product manufacturing

·   Extensive working knowledge of sterilisation/decontamination systems and industry practices.

·   Experience working with critical HVAC systems and qualification of AVS

·   Experience with APS/Media Fill

·   Demonstrate active listening and continuous feedback within team, ability to facilitate problem solving, decision making, and issue resolution

·   Demonstrate ability to successfully interact with other functions on projects that involve negotiation and collaboration with cross-functional peers and more senior management levels.

·   Strong program and change management skills

·   Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment

·   Comfortable in a fast-paced, dynamic, and highly fluid company environment with works under consultative direction toward pre-determined long-range goals and objectives.

·   Able to adjust workload based upon changing priorities

·   Previous people management experience highly desired.

·   Able to express ideas and present information effectively to Amgen leadership, within team functions, and with external partners

·   Ability to think critically with demonstrated troubleshooting and analytical skills