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 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 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.