Senior Validation Engineer

Position: Senior Validation Engineer (Permanent/Full-Time)
Job Description
Core Factor is searching for a Senior Validation Engineer on a permanent/full-time basis for a client located in Albany NY.

This position is onsite and requires the successful incumbent to be onsite five (5) days per week.

Our client is an FDA-registered 503B outsourcing facility manufacturing sterile compounded pharmaceutical products in Albany, NY. Their product portfolio includes a controlled substance nasal spray (P1: Sufentanil/Ketamine) and an intrathecal injectable (P2: Baclofen). They are post-execution of a 90-day production readiness program and now bringing daily validation operations in-house as they move from inspection readiness to full commercial production.

Role overview

The Senior Validation Engineer owns the organization's day-to-day validation program across facilities, equipment, processes, and computerized systems. You will be the single point of accountability for inspection-readiness across approximately 51 deliverables (D01-D50) currently maintained by a consulting team, and will execute the daily work that keeps

503B operations in a state of validated control. This role consolidates work previously distributed across a 5-person external consulting team into one full-time on-site role, supplemented by specialty vendors (HEPA testing, smoke studies, terminal sterilization studies) on an as-needed basis.

You will not be designing the program from scratch - the documentation framework is built. You will be executing, maintaining, and remediating it daily, escalating blockers proactively, and producing evidence in the format management has established (photo-before / action / photo-after for facilities, signed-off summaries for trackers, controlled documents routed through Master Control).

What You'll Own:

Facilities Validation (Primary)

• HVAC System PQ - 3 Carrier AHUs (F-1, F-2, F-4) for classified areas, F-3/F-5 non-classified; 38 HEPA filters across 1F + 2F; differential pressure cascades; air change rates (≥20 ACH; current actuals 127 1F / 132 2F sterile prep); temperature/humidity verification
• ISO 14644-1/2 cleanroom certification for CR-A (1F) and CR-B (2F), including particle counts at-rest and operational, recovery time testing, annual recertification
• Equipment Performance Qualification for ~22 pieces: 14 LAFWs, 3 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 against Dickson OCEAView CMS (32 sensors)
• Dynamic smoke studies under worst-case conditions per FDA Aseptic Processing Guidance; coordinate with ENV Services for execution
• Surface remediation programs - visual assessment, cleaning agent compatibility, remediation punch lists with photo evidence, contractor coordination, post-remediation verification

Process & Product Validation (Joint with PIC, Production)

• Author/maintain Master Batch Records (MBRs) per 21 CFR  for both products
• Maintain Critical Process Parameter (CPP) and Critical Material Attribute (CMA) documentation per ICH Q8(R2)
• Maintain Failure Mode and Effects Analysis (FMEA) per ICH Q9, including S/O/D scoring, RPN calculations, mitigation plans
• Process Performance Qualification (PPQ) protocols with statistically justified acceptance criteria
• Stability protocols per ICH Q1A(R2);
  Beyond-Use Date (BUD) justification per USP
• Container Closure Integrity Testing (CCIT) per USP : vacuum decay for P1 vials, HVLD for P2 pre-filled syringes
• Extractables & Leachables (E&L) studies per ICH Q3D / USP /
• Media fill protocols per FDA Aseptic Processing Guidance; coordinate execution with production team
• Cleaning validation with MACO calculations, swab/rinse sampling, dedicated vs shared equipment strategies

FDA Inspection Readiness:

• Maintain the FDA Inspection Package - master document index, CAPA records, pre-inspection checklist
• Drive CAPA closure on the 35 FDA observations currently tracked
• Mock inspection coordination; auditor escort
• Real-time response to State Board (NY OPD) and FDA inquiries

Operating Cadence

• Daily standups
• Week…