Title:  Validation Engineer

We are seeking an experienced and detail‑oriented Validation Engineer to support equipment, utility, packaging, and computerized system validations in a regulated pharmaceutical manufacturing environment. This role is critical to ensuring compliance with cGMP standards, regulatory expectations, and internal quality systems while supporting production and engineering initiatives.

What You’ll Be Responsible For:

In this role, you will lead and execute end‑to‑end validation activities across manufacturing, packaging, utilities, and supporting systems.

Key Responsibilities Include:

• Prepare, execute, and document URS, IQ, OQ, and PQ protocols and validation summary reports.
• Perform validations for production and packaging equipment and utility systems including:
  • HVAC
  • Air compressors
  • Boilers
  • Purified Water Systems
  • Area qualifications and warehouse temperature mapping
• Ensure all validation activities are completed on time and in compliance with cGMPs.
• Prepare and execute PLC validation protocols.
• Implement and maintain serialization and aggregation systems (e.g., Optel, Pharmaproof, Line Master), including cameras, scanners, and laser printers.
• Lead serialization packaging line IQ/OQ/PQ validations.
• Coordinate commissioning activities for new equipment and facility projects.
• Execute Periodic Performance Verification (PPV) activities.
• Develop calibration plans for newly installed equipment.
• Prepare, update, and conduct training for Setup, Operation, Cleaning, and Maintenance SOPs.
• Identify, investigate, and troubleshoot deviations across multiple concurrent projects.
• Design and document personnel, material, and waste flow throughout the facility.
• Support internal audits and regulatory inspections (FDA, DEA, and other agencies).
• Prepare, review, approve, and maintain Validation Project Plans, lifecycle documentation, and summary reports.
• Author and close investigations, change controls, and CAPAs in a timely manner.
• Develop SOPs for facilities and utilities.
• Monitor and follow up on maintenance work orders to ensure proper completion and documentation.

Education & Qualifications:

• Bachelor’s Degree in Engineering or related field.
• Strong technical and analytical skills to evaluate engineered systems, equipment performance, and quality systems.
• Solid understanding of cGMPs and Good Documentation Practices.
• Experience preparing and executing lifecycle documentation including:
  • URS, FRS, VMP
  • FAT, SAT, commissioning
  • IQ/OQ/PQ
  • SOPs, DS, CV, PV
  • FMEA and Validation Master Plans
• Technical writing experience for change controls, investigations, SOPs, validation protocols, and final reports.
• Excellent verbal, written, and presentation communication skills.
• Self‑motivated with a hands‑on, proactive mindset.
• Proven ability to collaborate cross‑functionally and support team success.
• Strong project management and problem‑solving skills.
• English language proficiency at CEFR Intermediate B1+ level.

Experience:

• Minimum 4 years of experience in pharmaceutical manufacturing
• Oral Solid Dosage (OSD) experience strongly preferred

Work Schedule:

Monday-Friday, 9:00am-5:30pm

Work Environment:

This position operates across:

• Corporate office settings
• Manufacturing and production areas
• Warehouse environments

Exposure may include noise, dust, fumes, odors, gases, and industrial hazards typical of pharmaceutical manufacturing operations.

Physical Requirements:

• Ability to stand, walk, sit, bend, stoop, kneel, crouch, crawl, push, and reach as needed.
• Lift, carry, or move up to 50 pounds.
• Navigate office, lab, and plant‑floor environments.
• Capable of wearing required personal protective equipment (PPE) including safety glasses, safety shoes, and respirators.

Why Join Us?

• Play a hands‑on role in maintaining regulatory compliance and product quality
• Work with advanced manufacturing, packaging, and serialization technologies
• Collaborate with cross‑functional engineering, quality, and operations teams
• Contribute directly to continuous improvement and operational excellence

Ready to make a difference? Apply today!