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

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

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

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

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.

• 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.

• 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.

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

• Waters Empower
• Lab Ware LIMS
• Lab Vantage
• Chromeleon
• Open Lab
• Electronic Laboratory Notebooks (ELN)
• Veeva
• Kneat

• Computerized Systems Validation (CSV)
• Audit Trail Reviews
• Data Integrity
• CAPA
• Change Control
• Inspection Readiness
• GAMP 5
• Laboratory Compliance

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.

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.