Computerized Validation SME - Lab

WaveCrest Staffing Group; Newark (CA); On-site; USD 120,000 - 160,000; Full time

Job summary

WaveCrest Staffing Group seeks a Validation SME in California to support validation of computerized systems, equipment, and instruments in a pharma/biotech setting. You will maintain existing validated systems, support change control, and data integrity assessments.

Responsibilities include coordinating periodic reviews, authoring lifecycle documentation, managing qualification and testing activities (OQ/UAT), reviewing test packages, and supporting system owners throughout the lifecycle.

Qualifications

• Bachelor's degree in a scientific discipline.
• 6–8 years of qualification/validation experience in pharma/biotech.
• Experience with CSV and/or CSA.
• Experience validating ERP, LIMS, MES, and/or DMS systems.
• Strong technical writing skills.
• Knowledge of 21 CFR Part 11, GAMP 5, MHRA Data Integrity Guidelines.
• SAP change management is a plus.

Responsibilities

• Coordinate and support routine periodic system reviews.
• Author and develop system lifecycle documentation (risk assessments, user requirements, test protocols).
• Coordinate, manage, and execute qualification and testing activities (OQ and UAT).
• Review completed test packages and address exceptions.
• Support system owners and stakeholders through system lifecycle activities.
• Coordinate and support data integrity assessments.
• Ensure electronic records and data integrity compliance.
• Lead or support system change control processes.
• Troubleshoot and resolve complex system issues.

Skills

CSV/CSA experience

Education

Bachelor's degree in a scientific discipline

Tools

ERP

LIMS

MES

DMS

SAP change management

Job description

Our client is seeking a Validation SME to support the validation of computerized systems, equipment, and instruments. This role will focus on maintaining existing validated systems, supporting change control, data integrity assessments, and periodic reviews. The ideal candidate has strong CSV/CSA experience, a background in pharmaceutical or biotech environments, and the ability to independently manage validation activities.

Responsibilities:

• Coordinate and support routine periodic system reviews.
• Author and develop system lifecycle documentation, including risk assessments, user requirement specifications, and test protocols.
• Coordinate, manage, and execute qualification and testing activities, including OQ and UAT.
• Review completed test packages, address exceptions, and support issue resolution.
• Support business owners, system owners, and stakeholders throughout system lifecycle activities.
• Coordinate and support data integrity assessments.
• Ensure electronic records, data integrity, and compliance requirements are met.
• Lead or support system change control processes.
• Troubleshoot and resolve complex system issues.

Requirements:

• Bachelor's degree in a scientific discipline.
• Minimum 6–8 years of qualification/validation experience within the pharmaceutical, biotech, or related industry.
• Must have CSV and/or CSA experience.
• Experience validating ERP, LIMS, MES, and/or DMS systems.
• Strong technical writing skills.
• Understanding of regulatory requirements and industry guidelines, including 21 CFR Part 11, GAMP 5, and MHRA Data Integrity Guidelines.
• Experience managing high-volume change control processes; SAP change management experience is a plus.
• Experience performing risk assessments and change-based impact assessments.
• Experience developing test strategies and designing right-sized test plans and protocols.
• Ability to independently organize, problem-solve, multitask, and prioritize responsibilities.
• Ability to work independently, escalate project issues, and meet established timelines.