Computer and Equipment Validation (contractor) - Contract

The role shall support the validation director to define validation / qualification requirements for new and existing systems, including issue tracking and resolution. Primary responsibilities include supporting operational activities for existing systems such as change control, data integrity assessments, and periodic review.

Computer and Equipment Validation
Newark, CA
12 Months
This is a 12-month contract opportunity in the Validation group. This role is expected to be full-time on-site at Newark, CA facility.

Description
Client is seeking a validation SME to support validation of computerized systems, equipment, and instruments (systems). Primary responsibilities include supporting operational activities for existing systems such as change control, data integrity assessments, and periodic review. The role shall support the validation director to define validation / qualification requirements for new and existing systems, including issue tracking and resolution. The role requires flexibility and independent work in a dynamic environment.

Duties and Responsibilities:
Periodic Review: Coordinate and support routine periodic system reviews
Validation: Author or support development of system lifecycle documents (e.g. risk assessments, user requirement specifications, test protocols)
Qualification / Testing: coordinate, manage and/or execute test protocols (e.g. OQ, UAT), address exceptions, and review completed test packages.
SDLC Support: support business owners, system owners, and other stakeholders through required system lifecycle activities.
Data Integrity: Coordinate and support data integrity assessments
Compliance: ensure relevant electronic record, data integrity and other compliance requirements are defined for new systems per Allogene procedures and regulatory expectations.
Change Control: Lead or support the system change control process as required
Supports and troubleshoots complex system issues

Skills:

Position Requirements & Experience:
A minimum B.S. degree in a scientific discipline is required
Minimum 6-8 years experience in qualifications/validations in the pharmaceutical or related industry
Must have CSV and/or CSA experience
Previous experience in ERP, LIMS, MES and/or DMS system validation is required
Technical writing
Sound understanding of regulatory requirements and industry guidelines (21 CFR Part 11, GAMP 5, MHRA Data integrity guidelines, etc.)
Experience with managing high-volume change control process, SAP change management a plus
Experience of performing risk and change based impact assessments
Experience with developing test strategies and designing right-sized test plans/protocols
Must be able to independently organization, problem solve, multitask and prioritize work
Work independently, escalate project issues and deliver results within established timelines

Candidates must be authorized to work in the U.S

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