Senior Project Validation Engineer - OQSIE

The NHSD projects goal is to modernize the current needle assembly manufacturing process. This will be achieved by A: Upgrading the manufacturing facility and B: Installing a modern custom built manufacturing machine.

A senior Project Validation Engineer is required to support the associated validation and commissioning activities of the project. The ideal candidate will have experience both in commissioning of new facility systems, (HVAC, Air Balancing, Smoke Studies, Fit and Finish verification, Utility systems) and new equipment startup and validation (Commissioning studies, Factory & Site acceptance testing, Installation Qualification IQ, Operational Qualification – OQ, Performance Qualification – PQ).

As the lead validation resource, the chosen candidate will be responsible for creating the project validation plan, in line with the site validation groups SOP’s. The validation lead will be responsible for building and coordinating a validation team of 2 to 3 persons to deliver project goals.

The role will report to both the Validation Manger and the Capital Project manager. The candidate is expected to be able to work independently and across multiple department groups. 

QUALIFICATIONS:

• Bachelor’s Degree in Engineering, Quality or related field
• 10+ years’ experience  in Equipment and Facility Engineering
• 10+ years’ experience  in pharmaceutical validation 
• Must have strong hands-on knowledge of pharmaceutical validation practices and procedures 
• Knowledge of current trends in pharmaceutical validation of aseptic manufacturing facilities
• Knowledge of regulatory compliance requirements for pharmaceutical aseptic manufacturing
• Proficient in Microsoft Office
• Ability to travel internationally with US passport current through 2020
• International Travel will be required for approx. 3 – 4 weeks
• Excellent self-management, time management, and problem solving skills – predict problems and find solutions
• Ability to be flexible, resilient, and adaptable to changing priorities in a fast paced, high pressure environment
• Ability to work effectively with a diverse workforce