Senior Startup cGMP Engineer | Building 503B Sterile Systems from Scratch | Validation, Quality

Position Summary

We are seeking a hands-on cGMP Engineer to implement, validate, and continuously improve manufacturing processes in a sterile 503B environment. This role bridges Engineering, Quality, and Production to ensure equipment, utilities, cleanrooms, and manufacturing processes remain qualified and inspection-ready in accordance with FDA regulations, USP standards, and data integrity principles. If you thrive in startup environments and enjoy building systems from scratch, we want to meet you.

Key Responsibilities

Validation & Qualification

• Author and execute IQ/OQ/PQ protocols for equipment, utilities, and cleanroom systems (HVAC, WFI/PW, autoclaves, filling, sterilizing filtration)
• Lead process validation activities for sterile compounding, aseptic filling, and terminal sterilization
• Develop and execute cleaning validation protocols
• Support commissioning, FAT/SAT, and production handover
• Support CSV activities for eQMS/MES/ERP/EM systems in alignment with 21 CFR Part 11

Manufacturing Process Engineering

• Design and optimize sterile manufacturing workflows (API dissolution, compounding, 0.2 µm sterilizing filtration, aseptic filling)
• Develop process flow diagrams, P&IDs, and critical process parameter documentation
• Conduct risk assessments (FMEA/HACCP), root cause investigations, and CAPA implementation
• Drive continuous improvement using Lean/Six Sigma and statistical tools

Cleanroom & Utilities

• Support qualification and monitoring of ISO 5/7/8 environments (HEPA integrity, smoke studies, pressure differentials, temp/humidity mapping)
• Oversee utility qualification/monitoring: WFI, PW, clean steam, compressed gases, HVAC
• Collaborate with Quality on environmental monitoring trend analysis

Compliance & Documentation

• Author SOPs, validation master plans, protocols, and summary reports
• Ensure compliance with 21 CFR 210/211, USP <797>/<795>/<800>, and 503B guidance
• Maintain audit-ready validation files and support inspections/audits
• Participate in change control, deviations, and CAPA as engineering SME
• Uphold ALCOA+ data integrity standards

Required Qualifications

• Bachelor’s degree in Engineering or related discipline (Chemical, Mechanical, Biomedical, Pharmaceutical, etc.)
• 2–5 years in a cGMP-regulated environment (pharma, biotech, med device, or 503B)
• Hands-on experience authoring/executing IQ/OQ/PQ protocols and summary reports
• Strong knowledge of FDA cGMP (21 CFR 210/211), validation lifecycle, and risk tools (FMEA)
• Experience in equipment qualification, process validation, and/or cleaning validation
• Excellent technical writing and communication skills

Preferred Qualifications

• Experience in 503B outsourcing and/or sterile pharmaceutical manufacturing
• Knowledge of USP <797>/<795>/<800> and cleanroom operations
• Utility system qualification experience (WFI/PW/HVAC/clean steam/compressed gases)
• Familiarity with 21 CFR Part 11, CSV, and electronic QMS/MES
• Lean Six Sigma Green Belt (or equivalent)
• Bilingual (English/Spanish) is a plus

Physical Requirements

• Ability to work in cleanroom gowning for extended periods
• Comfortable in controlled manufacturing environments

Compensation & Benefits

Competitive Compensation & Benefits