Validation Specialist - Cleaning

Validation Specialist - Cleaning (India Role to Support US Operations)

Hubot, Inc. India (Remote/Hybrid) | Full-Time | US Shift Overlap Required | Technical Support Role Reporting To: Sr. Validation Engineer (USA)

Hubot, Inc. is seeking a Validation Specialist - Cleaning to serve as the Technical Control Tower for our US operations. You will act as the Subject Matter Expert (SME), managing the technical strategy not just for cleaning, but for the Microbiology, Equipment, and Regulatory frameworks that support it. You will own the "Master Schedule," ensuring our US site never misses a revalidation, while keeping our protocols aligned with the latest USP, FDA, and ICH updates.

Why Join Hubot?

2530% YoY growth forecast through 2030

4.8 Glassdoor | 4.7 Indeed | 95% recommend | Well-being 79

Total Technical Oversight: You connect the dots between Equipment Design, Microbiology, and Cleaning Strategy.

The "Keeper of the Schedule": You own the Master Validation Plan timeline, ensuring US operations remain compliant 365 days a year.

Regulatory Guardian: You are the eyes and ears of the company, monitoring FDA/ICH updates to ensure we stay ahead of compliance curves.

What Youll Do (Technical Strategy & Oversight)

• Cleaning & Microbiology Strategy: Define the technical approach for bioburden control and swabbing techniques. You will draft the SOPs for swab recovery studies and microbial limits that US operators will execute.
• Equipment Validation Integration: Oversee the Equipment Qualification (IQ/OQ/PQ) lifecycle to ensure equipment design supports valid cleaning calculations (surface area determination, material compatibility).
• Regulatory Surveillance: Actively monitor USP, FDA (21 CFR), and ICH (Q3/Q7) updates. You will perform gap analyses and recommend protocol updates to US management to maintain state-of-the-art compliance.
• Master Schedule Management: Maintain the Validation Master Plan (MVP) and revalidation schedules for all Equipment, Utilities, and Cleaning processes. You alert the US team before validations expire.
• Advanced Calculations: Perform toxicological carryover calculations (ADE/PDE/MACO) utilizing both chemical and microbiological data points.
• Audit "War Room" Support: Prepare technical justification white papers linking our Equipment, Micro, and Cleaning strategies to defend against FDA audit queries.

Who You Are (Multi-Disciplinary SME)

• Education: B.Pharm / M.Pharm, Microbiology, or Chemical Engineering degree.
• Experience: 8+ Years in Validation, with specific proficiency in Microbiology and Equipment Qualification as they relate to Cleaning Validation.
• The "Regulatory Watchdog": You read FDA warning letters and USP updates for fun. You know when the rules change before anyone else does.
• Project Manager Mindset: You can track hundreds of equipment revalidation dates and ensure nothing falls through the cracks.

Must-Have Skills

• Microbiology & Swabbing: Deep understanding of swab recovery techniques, TPC/Bioburden limits, and USP <61>/<62>.
• Cleaning Validation Math: Proficiency in MACO, ADE, and PDE calculations.
• Equipment Qualification: Strong knowledge of IQ/OQ/PQ for manufacturing (tanks/fillers) and utilities (HVAC/Water).
• Regulatory Intelligence: Familiarity with ICH Q3 (Impurities), FDA Process Validation Guidance, and EudraLex Annex 15.
• eQMS & Scheduling: Expert-level skill in DOT Compliance and Validation Lifecycle Management.

Success Metrics

• 0% Overdue Validations: The Master Validation Plan is always current; no equipment goes past its revalidation date.
• Regulatory Readiness: Gap analyses on new FDA/USP guidelines are submitted to US management within 30 days of release.
• Audit Defense: Technical data packages are delivered within agreed timelines during inspections.

Benefits Competitive Salary, Company Laptop, We-Work Membership, Reimbursement for Internet/Travel (if required). Work where you are HAPPY!

www.hubot.us Thank you for your interest and consideration of a career with Hubot. Hubot is an Equal Employment Opportunity / Affirmative Action Employer.