Validation Specialist

Overview

We are looking for a Validation Specialist to join a prominent pharmaceutical company as it expands its facility. This role is a fully onsite contract position for an initial duration of 12 months.

Primary Duties

• Perform thorough review, auditing, and closure of validation documentation such as Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) protocols, Validation Summary Reports (VSRs), and cleaning validation records.
• Ensure all validation documentation adheres strictly to current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GxP), data integrity standards, and 21 CFR Part 11 regulations.
• Conduct and assess cleaning validation activities for bioprocessing equipment including bioreactors, chromatography systems, process skids, and parts washers used in upstream and downstream processes.
• Evaluate swab and rinse samples along with analytical results and acceptance criteria to facilitate validation approvals.
• Collaborate closely with Quality Assurance (QA), Quality Control (QC), Manufacturing, Engineering, and Validation departments to secure documentation approvals and reviews.
• Manage validation documents using electronic document management systems, maintaining accuracy, versioning, and traceability of files.
• Address documentation inconsistencies and assist in resolving open validation records.
• Enhance document management processes to improve readiness for audits and regulatory inspections.
• Support inspection activities by ensuring all validation documents are complete, compliant with regulations, and easily accessible.
• Adhere to internal quality systems, Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) rules, European Union Good Manufacturing Practices (EU GMP), and other regulatory guidelines.

Required Qualifications

• Bachelor's degree in Engineering, Microbiology, Life Sciences, Biotechnology, or a closely related field.
• Over three years of professional experience in Commissioning & Qualification, Validation, or combined CQV work within GMP-governed pharmaceutical or biotech settings.
• Experience supporting QC Analytical and/or QC Microbiology laboratories.
• Practical experience executing IQ/OQ/PQ protocols for laboratory instruments and equipment.
• Familiarity with coordinating preventive maintenance and calibration for laboratory equipment.
• Understanding of the validation lifecycle documentation and GMP document control standards.
• Experience using Quality Systems, including Change Controls, Deviations, and Corrective and Preventive Actions (CAPAs).
• Knowledge of quality management software such as LIMS, TrackWise, Veeva, EDMS, or similar is considered a plus.