System Level Review (SLR) & Audit Trail Review (ATR) Consultant - GxP Laboratory Systems Location: Collegeville, PA (100% Onsite)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. What you'll be doing*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.
Required Qualifications*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 ExperienceExperience 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 System Validation (CSV)
*Data Integrity
*Audit Trail Reviews
*System Level Reviews
*Laboratory Compliance
*Risk Assessment
*CAPA
*Change Control
*Root Cause Analysis
*GAMP 5
*Good Manufacturing Practice (GMP)
*Laboratory Information Management Systems (LIMS)
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.