System Level Review (SLR) & Audit Trail Review (ATR) Consultant - GxP Laboratory Systems

System Level Review (SLR) & Audit Trail Review (ATR) Consultant - GxP Laboratory Systems, Alphanumeric is seeking an experienced System Level Review (SLR) & Audit Trail Review (ATR) Consultant to support a leading global pharmaceutical organization at its Collegeville, PA campus.

This role is ideal for a Computerized System Validation (CSV) professional with hands-on experience supporting laboratory equipment and computerized systems in a regulated GxP environment. The successful candidate will perform System Level Reviews, Audit Trail Reviews, and Data Integrity assessments while ensuring laboratory systems remain compliant, inspection-ready, and aligned with FDA regulatory expectations.

Candidates with experience performing Periodic Reviews, Computerized System Reviews, or equivalent laboratory system compliance assessments are encouraged to apply.

Responsibilities

• Perform System Level Reviews (SLRs) for laboratory equipment and computerized systems.
• Execute Audit Trail Reviews (ATRs) to evaluate system compliance, electronic records, and data integrity.
• Assess laboratory systems for compliance with GxP, FDA 21 CFR Part 11, and applicable regulatory requirements.
• Review audit trails, electronic records, user access, security controls, system configurations, and lifecycle documentation.
• Identify data integrity risks, compliance gaps, and opportunities for remediation.
• Author and review validation documentation, including risk assessments, validation plans, protocols, reports, periodic reviews, and change controls.
• Support Computerized System Validation (CSV) activities throughout the system lifecycle.
• Partner with Quality Assurance, Validation, Laboratory Operations, Engineering, and IT teams to ensure systems remain in a validated state.
• Support internal audits, regulatory inspections, and inspection readiness initiatives.
• Ensure validation deliverables meet established quality standards and project timelines.

• Bachelor’s degree in Engineering, Computer Science, Chemistry, Biology, Life Sciences, or a related technical discipline.
• Minimum 5 years of experience supporting GxP-regulated pharmaceutical, biotechnology, or life sciences environments.
• Hands-on experience performing Computerized System Validation (CSV).
• Experience conducting System Level Reviews (SLRs), Periodic Reviews, and/or Audit Trail Reviews (ATRs) for laboratory equipment or computerized systems.

Strong knowledge of:

• GxP
• FDA 21 CFR Part 11
• Data Integrity (ALCOA+)
• Electronic Records and Electronic Signatures
• Change Control and Risk Assessment
• Experience supporting laboratory computerized systems and laboratory equipment.
• Strong technical writing, documentation, and communication skills.

Preferred Experience

Experience with one or more of the following systems is highly desirable:

• Waters Empower
• LabWare LIMS
• LabVantage
• Chromeleon
• OpenLab
• Electronic Laboratory Notebooks (ELN)
• Veeva
• Kneat
• ValGenesis

Preferred Skills

• Computerized Systems Validation (CSV)
• Audit Trail Reviews
• System Level Reviews
• Data Integrity
• CAPA
• Risk Assessment
• Change Control
• Root Cause Analysis
• Inspection Readiness
• GAMP 5
• Laboratory Compliance

Why Join Us?

This is an opportunity to support highly visible compliance initiatives within a global pharmaceutical organization. You’ll work alongside cross-functional Quality, Validation, Engineering, and Laboratory teams on projects that directly impact regulatory compliance, data integrity, and inspection readiness.

Please Note: This is a 100% onsite position located in Collegeville, PA. Candidates must be authorized to work in the United States on a W2 basis. We are unable to accept third-party candidates or provide sponsorship now or in the future.

Pay: $70-85/hour W2 (depending on experience)

Benefits: Medical, Dental, Vision, 401(k), PTO, Paid Holidays, and more.