Project 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 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.
• 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 Criteria

Provide ETL Support Services to support the project

• Scope of facilities
• Project requirements
• Design Plan
• Design review reports
• Design qualification report
• Conceptual design documents
• e-Builder processes
• Submittals
• RFIs
• Turnover packages
• Engineering Change Notices
• 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.