Senior Validation Engineer (Permanent/Full-Time)
About The Position
CoreFactor is seeking a Senior Validation Engineer for a permanent, full-time, onsite position in Albany, NY. The client is an FDA-registered 503B outsourcing facility that manufactures sterile compounded pharmaceutical products. This role is crucial for bringing daily validation operations in-house as the company transitions from inspection readiness to full commercial production. The Senior Validation Engineer will be the primary owner of the organization's day-to-day validation program, encompassing facilities, equipment, processes, and computerized systems. This position consolidates the work of a previous 5-person external consulting team into a single on-site role, with support from specialty vendors as needed. The role involves executing, maintaining, and remediating the existing validation program, proactively escalating issues, and producing evidence in the established format.
Requirements
- Bachelor’s degree in Pharmaceutical Sciences, Chemical Engineering, Mechanical Engineering, Microbiology, Analytical Chemistry, or related scientific/engineering discipline.
- 5+ years of direct experience in process and/or facilities validation within FDA-regulated pharmaceutical manufacturing (503B, 503A, or conventional sterile pharma).
- Demonstrated expertise in sterile/aseptic manufacturing process validation, including media fills, environmental monitoring, and cleaning validation.
- Deep knowledge of: 21 CFR Parts 210/211 (cGMP), 21 CFR Part 11 (electronic records), FDA Process Validation Guidance (January 2011), FDA Aseptic Processing Guidance (September 2004), ICH Q8(R2), Q9, Q10, USP <71>, <85>, <797>, <905>, <1207>, <1663>, <1664>, ISO 14644-1/2, IEST-RP-CC034 (HEPA testing).
- Hands-on experience writing and executing PPQ protocols, MBRs, FMEAs, cleaning validation protocols, and HVAC PQ protocols.
- Computer System Validation (CSV) experience with at least 2 of: QMS, MES, ERP, EMS, LIMS.
- Strong written documentation discipline (pristine grammar, no typos, no ambiguity).
- Strong escalation discipline (proactively identifying blockers and required actions).
Responsibilities
- Own the organization’s day-to-day validation program across facilities, equipment, processes, and computerized systems.
- Serve as the single point of accountability for inspection-readiness across approximately 51 deliverables.
- Execute daily work to maintain 503B operations in a state of validated control.
- Execute, maintain, and remediate the validation program daily.
- Escalate blockers proactively.
- Produce evidence in the established format (photo-before / action / photo-after for facilities, signed-off summaries for trackers, controlled documents routed through MasterControl).
- Facilities Validation: Manage HVAC System PQ (Carrier AHUs, HEPA filters, differential pressure cascades, air change rates, temperature/humidity verification), ISO 14644-1/2 cleanroom certification (particle counts, recovery time testing, annual recertification), Equipment Performance Qualification (~22 pieces including LAFWs, BSCs, balance enclosures, repeater pumps, hot plate stirrers, depyrogenation oven, autoclaves, stability chambers), Building Management System (BMS) validation (Distech EC-BACnet controllers, Vaisala sensors, Ebtron airflow stations, Setra differential pressure transmitters; correlation studies), Dynamic smoke studies, Surface remediation programs (visual assessment, cleaning agent compatibility, remediation punch lists, post-remediation verification).
- Process & Product Validation: Author/maintain Master Batch Records (MBRs), maintain Critical Process Parameter (CPP) and Critical Material Attribute (CMA) documentation, maintain Failure Mode and Effects Analysis (FMEA), execute Process Performance Qualification (PPQ) protocols, manage Stability protocols and Beyond-Use Date (BUD) justification, oversee Container Closure Integrity Testing (CCIT), manage Extractables & Leachables (E&L) studies, manage Media fill protocols, and execute Cleaning validation.
- FDA Inspection Readiness: Maintain the FDA Inspection Package (master document index, CAPA records, pre-inspection checklist), drive CAPA closure on FDA observations, coordinate mock inspections, and escort auditors.
- Manage daily standups, weekly progress reports, photo evidence collection, controlled document routing, and vendor coordination.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
