Computer And Equipment Validation (Contractor) - Contract

TalentBurst, Inc.Newark, CA

$80 - $83 / hour

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Overview

Remote

On-site

Compensation

$80-$83/hour

Job Description

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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FAQs About Computer And Equipment Validation (Contractor) - Contract Jobs at TalentBurst, Inc.

What is the work location for this position at TalentBurst, Inc.?

This job at TalentBurst, Inc. is located in Newark, CA, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.

What pay range can candidates expect for this role at TalentBurst, Inc.?

Candidates can expect a pay range of $80–$82.76 per hour for this role.

What employment applies to this position at TalentBurst, Inc.?

The employer has not provided this information. This may be discussed during the hiring process.

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You can apply for this role at TalentBurst, Inc. either through Sonara's automated application system, which helps you submit applications 10X faster with minimal effort, or by applying manually using the direct link on the job page.