cGMP Engineer (Permanent)

CoreFactor is searching for a cGMP Engineer for a client in Albany, NY on full-time/permanent basis.

Our client is an FDA-registered 503B outsourcing facility in Albany, NY manufacturing sterile compounded preparations for hospitals, health systems, and clinics nationwide. Their facility features two ISO-classified sterile cleanroom suites with digital-first production documentation, barcode-driven traceability, and a formalized quality management system built to exceed cGMP expectations. They are in an exciting launch phase of building, validating, and qualifying their manufacturing processes before commencing commercial production.

Position Summary

We are seeking a hands-on cGMP Engineer to implement, validate, and continuously improve manufacturing processes within our clients 503B sterile compounding facility. This role is central to bridging engineering, quality, and production by ensuring that all equipment, utilities, cleanroom systems, and manufacturing processes are qualified, validated, and maintained in a state of cGMP compliance per FDA regulations and USP standards.

This is a ground-floor opportunity for an engineer who thrives in startup-scale environments, is energized by building systems from scratch, and takes ownership of documentation discipline and regulatory readiness.

Key Responsibilities

• Process Validation and Equipment Qualification Author, review, and execute IQ/OQ/PQ protocols for manufacturing equipment, utilities, and cleanroom systems (HVAC, WFI/PW systems, autoclaves, filling equipment, sterilizing filtration systems)
• Lead process validation activities for sterile compounding operations including sterilizing filtration, aseptic filling, and terminal sterilization processes
• Develop and execute cleaning validation protocols for product-contact equipment and cleanroom surfaces
• Perform equipment commissioning, FAT/SAT (Factory/Site Acceptance Testing), and turnover to production
• Support Computer System Validation (CSV) for electronic QMS, MES, ERP, and environmental monitoring systems per 21 CFR Part 11
  
  

Manufacturing Process Engineering

• Design, optimize, and document sterile manufacturing processes including API dissolution, compounding, sterilizing filtration (0.2 um), and aseptic fill operations
• Develop and maintain process flow diagrams, P&IDs, and critical process parameter specifications
• Perform process risk assessments (FMEA, HACCP) to identify and mitigate risks to product quality and patient safety
• Conduct root cause analysis and implement corrective actions for process deviations, equipment failures, and out-of-specification results
• Drive continuous improvement initiatives using Lean, Six Sigma, and statistical process control methodologies
  
  

Cleanroom and Facility Systems Engineering

• Support qualification and ongoing monitoring of ISO-classified cleanroom environments (ISO 5/7/8) including HEPA filter integrity testing, airflow visualization (smoke studies), room pressure differential verification, and temperature/humidity mapping
• Oversee utility system qualification and monitoring: Water for Injection (WFI), Purified Water (PW), clean steam, compressed gases, and HVAC systems
• Support environmental monitoring program design and data trending in collaboration with Quality
  
  

Documentation and Regulatory Compliance

Author and maintain engineering SOPs, validation master plans, protocols, summary reports, and technical documentation per cGMP requirements

Ensure all engineering activities comply with FDA 21 CFR 210/211, USP //, and applicable FDA 503B guidance

Maintain audit-ready validation files and support FDA inspections, state board of pharmacy audits, and internal quality audits

Participate in change control, deviation investigations, and CAPA processes as the engineering subject matter expert Ensure all documentation follows ALCOA data integrity principles

Cross-Functional Collaboration

• Partner with Production, Quality Assurance, and Quality Control to ensure validated processes translate to reliable, repeatable manufacturing operations
• Support training of production operators on equipment operation, process parameters, and cGMP behaviors Coordinate with external vendors, contractors, and equipment suppliers for installation, calibration, and maintenance services
• Contribute to management review, annual product quality reviews, and regulatory submission support
  
  

Requirements

REQUIRED QUALIFICATIONS

• Bachelor's degree in Chemical Engineering, Mechanical Engineering, Biomedical Engineering, Pharmaceutical Engineering, or related engineering/science discipline
• 2-5 years of experience in a cGMP-regulated manufacturing environment (pharmaceutical, biotech, medical device, or 503B facility)
• Hands-on experience authoring and executing IQ/OQ/PQ validation protocols and summary reports
• Strong knowledge of FDA cGMP regulations (21 CFR 210/211), validation lifecycle methodology, and risk assessment tools (FMEA)Experiencewith equipment qualification, process validation, and/or cleaning validation in a manufacturing setting
• Solid understanding of cGMP documentation practices, SOPs, and data integrity principles
• Strong analytical and problem-solving skills with experience in root cause analysis and CAPA
• Proficiency with Microsoft Office Suite (Excel, Word, Visio); experience with statistical tools (Minitab) a plus
• Excellent written and verbal communication skills; ability to author clear, audit-ready technical documents
  
  

Preferred Qualifications

Experience in a 503B outsourcing facility or sterile pharmaceutical manufacturing environment

Knowledge of USP // and cleanroom operations (ISO 5/7/8)

Experience with utility system qualification (WFI, PW, HVAC, clean steam, compressed gases)

Familiarity with 21 CFR Part 11, CSV, and electronic QMS/MES platforms

Lean Six Sigma Green Belt or equivalent continuous improvement certification

Experience with sterilizing filtration, aseptic processing, or autoclave validation

Bilingual (English/Spanish) is a plus

Physical Requirements

• Ability to work in cleanroom environments with full gowning for extended periods
• Must be able to lift up to 40 lbs and work around manufacturing equipment
• Comfortable working in environments with varying temperatures and controlled conditions