Senior Validation Specialist — Computer & Equipment Systems (CSV)

TalentBurst, Inc; Newark (CA); In loco; USD 90.000 - 130.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical benefits

Dental benefits

Retirement options

Descrizione del lavoro

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).

Competenze

• 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.

Mansioni

• 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.

Conoscenze

Technical writing

Formazione

B.S. degree in a scientific discipline

Strumenti

ERP systems

LIMS

MES

DMS systems

Descrizione del lavoro

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).