Engineering Technical Leads ETL

Engineering Technical Leads ETLs

Provide ETL Support Services.

Project Scope

• Preparation of front-end planning documents.
• Lead the design process.
• 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 specifications
• Identification 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.
• 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 Criteria

• Scope of facilities
• Project requirements
• Design Plan
• Design review reports
• e-Builder processes
• RFIs
• Turnover packages
• Other Activities
• Field 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.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.