Validation Engineering

Responsibilities Support development and execution of validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for equipment, utilities, and processes

Assist in authoring and executing Computer System Validation (CSV) protocols for GxP systems in compliance with 21 CFR Part 11 and GAMP 5 principles

Support process validation activities, including protocol development, execution, and data collection for new and existing manufacturing processes

Assist with cleaning validation studies, including sampling, protocol execution, and documentation

Document validation results, deviations, and discrepancies, and support root cause analysis and resolution

Collaborate with Manufacturing, Quality Assurance, Process Engineering, and Automation teams to coordinate validation activities and timelines

Support authoring and updating validation master plans, risk assessments, and validation summary reports

Assist with change control activities related to equipment, process, or system modifications requiring revalidation

Support internal audits and prepare for external regulatory inspections (FDA, ISO) by compiling validation documentation and data

Ensure all validation activities and documentation comply with FDA regulations, cGMP, and internal quality standards

Participate in continuous improvement initiatives to streamline validation processes and reduce cycle times

Maintain accurate, audit-ready documentation for all validation protocols, execution records, and reports

Qualifications Required:

Bachelor\'s degree in Engineering (Chemical, Mechanical, Biomedical, Industrial, Pharmaceutical, or related field) or related science discipline

0–2 years of relevant experience (internships, co-ops, or entry-level validation/quality roles in pharma/biotech/med device count)

Basic understanding of cGMP, FDA regulations (21 CFR Part 210/211, Part 11), and validation lifecycle (IQ/OQ/PQ)

Familiarity with validation documentation practices, including protocol writing and execution

Proficiency with MS Office (Excel, Word, PowerPoint); familiarity with validation/quality management software a plus

Strong written and verbal communication skills, with the ability to author clear, audit-ready technical documentation

Ability to work effectively in a cross-functional, highly regulated team environment

Willingness to work on the production floor, including gowning/cleanroom protocols as required

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