Computer and Equipment Validation (contractor)

TalentBurst, an Inc 5000 company; Newark (CA); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Retirement options

Job summary

TalentBurst, Inc. seeks a Computer and Equipment Validation SME to support validation of computerized systems, equipment, and instruments in Newark, CA.

This 12-month contract is on-site and full-time at the Newark facility. Responsibilities include writing and coordinating system lifecycle documents, risk assessments, test protocols, change control, data integrity assessments, and regulatory alignment (21 CFR Part 11, GAMP 5).

Qualifications

• B.S. degree in a scientific discipline is required.
• 6–8 years experience in qualifications/ validations in pharma or related industries.
• CSV and/or CSA experience is required.
• Experience validating ERP, LIMS, MES and/or DMS systems.
• Technical writing experience is required.
• Knowledge of 21 CFR Part 11, GAMP 5, MHRA data integrity guidelines.

Responsibilities

• Coordinate and support periodic system reviews.
• Author or support development of system lifecycle documents (risk assessments, user requirements, test protocols).
• Coordinate, manage and/or execute test protocols (OQ, UAT); address exceptions.
• Support system lifecycle activities with system owners and stakeholders.
• Coordinate data integrity assessments.
• Define compliance requirements for new systems per Allogene procedures and regulatory expectations.
• Lead or support system change control processes.
• Troubleshoot complex system issues.

Skills

Technical writing

Education

B.S. degree in a scientific discipline

Tools

ERP systems

LIMS

MES

DMS systems

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

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, elevate project issues and deliver results within established timelines

Candidates must be authorized to work in the U.S

We offer competitive compensation and comprehensive benefits, including medical, dental, vision, and retirement options.

TalentBurst is an equal opportunity employer committed to an inclusive and diverse workforce.