A Validation Specialist tests and documents the validity and accuracy of manufacturing systems and equipment. Tests processes and manages process validations. Provides technical support and implements operating procedures. May create documentation to show that a manufacturing or production process has consistent results and meets quality standards.
System Level Review (SLR) & Audit Trail Review (ATR) Consultant - GxP Laboratory Systems at Alphanumeric Systems System Level Review (SLR) & Audit Trail Review (ATR) Consultant - GxP Laboratory Systems at Alphanumeric Systems in collegeville, Pennsylvania Posted in 14 days ago.
Medical, Dental, Vision, 401(k), PTO, Paid Holidays, and more. About the Opportunity 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. Required Experience 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.
