Engineering Technical Lead (ETL)

Job DescriptionJob DescriptionValidation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:Engineering Technical Leads ETLsProject Scope:Provide ETL Support Services.Preparation of front-end planning documents.Lead the design process.Provide value engineering / creative problem solving.Participation in the development of the sourcing strategy for projects.Evaluate the design library against the project scope and issue relevant specifications or standards.Review of the projects plans for adherence to Amgen engineering standards and specificationsIdentification of possible deviations to the site specifications. Submittal and approval of variance.Ensure Factory Mutual loss prevention recommendations are issued and addressed in the design.Ensure EHSS requirements are considered in the design.Technical support during project execution and lead for discrepancies.Liaison to engineering technical authorities, subject matter experts, consultants, and engineer of record.RFI and submittal review process.Track design progress against plan and ensure alignment with overall project’s schedule.Engineering change management.Consultant to site commissioning and qualification work stream.Consultant to site change control evaluation process.Point of contact between equipment vendors and the site.Establish method to manage information and documents. e-Builder preferred for capital projects.Factory acceptance test planning.Ensure project plans and details are fit to introduce equipment.Develop, submit, and approve design qualification report (for level 1 systems), and DDR for level 2 and 3.Delivery CriteriaProvide ETL Support Services to support the projectScope of facilitiesProject requirementsDesign PlanDesign review reportsDesign qualification reportConceptual design documentse-Builder processesSubmittalsRFIsTurnover packagesEngineering Change NoticesOther ActivitiesField visits to confirm existing documentation and installations.Qualifications:Bachelor's Degree in Science or Engineering.Minimum of 5 years of experience in direct pharmaceutical, medical device or biotechnology industries.Must be fully bilingual (English / Spanish) with excellent oral skills.Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.Technical Writing skills and investigations processes.Available to work extended hours, possibility of weekends and holidays.#LI-ZL1