Senior Validation Engineer (Permanent/Full-Time)

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 MasterControl).

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 211.186–188 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 <797>
  
• Container Closure Integrity Testing (CCIT) per USP <1207>: vacuum decay for P1 vials, HVLD for P2 pre-filled syringes
  
• Extractables & Leachables (E&L) studies per ICH Q3D / USP <1663>/<1664>
  
• 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 
  
• Weekly progress report 
  
• Photo evidence
  
• Controlled document routing 
  
• Vendor coordination 
  

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 — your protocols and reports will be read by FDA inspectors; pristine grammar, no typos, no ambiguity
  
• Strong escalation discipline — when something is blocked, you write a single email naming the blocker, the owner, the deadline at risk, and the action you need from management. You do not let things sit.