Senior Validation Engineer (Permanent/Full-Time)

CoreFactor 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 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 Container Closure Integrity Testing (CCIT) per USP : vacuum decay for P1 vials, HVLD for P2 pre-filled syringesExtractables & 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
• 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 , , , , , ,

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.