Validation Specialist

Job Description

Job Description

Full Time Contract

The Validation Specialist supports commissioning and qualification (C&Q) activities associated with capital projects and technical initiatives within regulated pharmaceutical and biotechnology manufacturing environments.

This role is responsible for supporting protocol development, field execution activities, equipment startup, commissioning and qualification documentation, and technical coordination associated with regulated systems. Projects may support manufacturing systems, process equipment, packaging systems, clean utilities, facilities, cleanroom environments, process improvements, utilities infrastructure, automation-related systems, or other regulated operational systems.

The position requires strong technical documentation capabilities, field coordination skills, and active collaboration with Engineering, Operations, Quality, vendors, and project teams to ensure compliant and timely project execution.

• Protocol & Deliverable Generation: Author, review, and execute commissioning and qualification (C&Q) protocols (IQ, OQ, PQ, FAT, SAT) and related technical qualification packages.
• Field Execution & Startup: Lead and support field execution activities, including equipment verification, operational testing, startup support, and readiness coordination.
• Data Integrity & Documentation: Document all test results, protocols, and execution records in strict compliance with applicable Good Manufacturing Practices (cGMP) and ALCOA data integrity expectations.
• Turnover & Documentation Review: Support the collection, review, organization, and turnover of commissioning, qualification, and vendor test packages.
• Deviations & Punch List Management: Identify, document, and manage execution deviations, non-conformances, punch-list items, and technical discrepancies through resolution and closure.
• Field Scheduling & Coordination: Support the scheduling and cross-functional coordination of testing activities, field resources, vendors, and project timelines.
• Project Communication: Actively participate in project meetings and communicate execution status, technical risks, action items, and field observations to leadership.
• Regulatory & Safety Compliance: Ensure all field and documentation activities comply with site Standard Operating Procedures (SOPs), safety regulations, FDA guidelines, and client quality standards.

• Experience: Minimum of 2 years of direct Commissioning & Qualification (C&Q), validation, startup, or field execution experience in a regulated cGMP environment.
• Technical Scope: Experience in one or more key areas:
  • Process & Manufacturing Equipment (OSD, Parenterals, Biologics)
  • Clean Utilities (Purified Water, WFI, Clean Steam, Process Gases)
  • Facilities, HVAC, Client/VAV, & Cleanroom Environments
  • Packaging Lines & Automation Systems
• Regulatory Knowledge: Solid understanding of cGMP regulations (21 CFR Parts 210/211/11), GAMP 5, and Data Integrity (ALCOA ) principles.
• Systems Proficiency: Familiarity with digital validation and quality systems such as Kneat, TrackWise, OneTrack, Maximo, or document management platforms (e.g., Veeva, C-DOCs) is strongly preferred.
• Language Skills: Excellent written and verbal communication skills in both English and Spanish (bilingual requirement for Puerto Rico operations), including technical writing and protocol drafting.
• Core Competencies: Strong organizational, troubleshooting, and analytical skills with the ability to manage multiple priorities and field activities simultaneously.

• Bachelor's degree in Engineering (Chemical, Mechanical, Biomedical, Industrial), Science (Chemistry, Biology, Biotechnology)