• Biochemical
• CGMP
• Laboratory

Validation Engineer
Primarily responsible for the support and execution of laboratory equipment validation and
associated computer system validation activities in compliance with current cGMP regulations
and Roche/Genentech corporate principles, quality policies, standards, and core values. You will
work closely with instrument vendors, facilities, IT and lab personnel to coordinate the,
installation and the qualification including computer system validation, of QC Equipment.
Reader.
 Perform qualification of laboratory equipment in accordance with EQ policies, plans
and procedures.
 Coordinate with laboratory personnel to define qualification requirements.
 Author, review and execute equipment qualification protocols.
 Coordinate equipment qualification activities with vendors and other support
groups.
 Coordinate equipment maintenance activities with vendors and other support
groups, as required.
 Identify business, quality, and compliance gaps and propose and implement
potential improvements to systems and procedures
 Sign documents for activities as authorized and described by Genentech policies,
procedures and job descriptions.
 Provide input to technical / investigation reports.
 Identify, troubleshoot, and propose resolution to technical problems.
 Receive and provide training.
 Provide input to and participate in assay transfer/validation associated with
equipment qualification/lifecycle.
 Coordinate with customers to support multi-site operational activities.
 Present equipment lifecycle and associated procedures/material during internal
and external audits and regulatory inspections.
 Works to meet schedules and set timelines.
 Perform other duties as requested by managers to support Quality activities.

Education:

•  Bachelors degree (Life Science, Engineering)

Experience (may vary depending on site size/scope)

• Three to six years of validation experience (or equivalent experience) in a cGMP environment with increasing levels of responsibility for a wide range of validation projects including validation of large scale biochemical manufacturing, utility and automation systems.

Pay Range: $60 - $80/hour

- Health, dental, vision, 401k

• Work Authorization : Green Card, US Citizen
• Preferred years of experience : 3+ Years
• Travel Required : No travel required
• Shift timings: Not specified