Position Overview
We are seeking an experienced
Validation Engineer with Commissioning, Qualification & Validation (CQV) experience to support projects within the life sciences industry. The successful candidate will be responsible for executing and documenting commissioning, qualification, and validation activities for facilities, utilities, equipment, systems, and manufacturing processes in accordance with applicable regulatory requirements and Good Manufacturing Practices (GMP).
This role requires strong technical documentation skills, attention to detail, and the ability to work collaboratively with Engineering, Quality, Manufacturing, Automation, and Project Management teams.
Key Responsibilities
- Execute and support Commissioning, Qualification & Validation (CQV) activities for pharmaceutical, biotechnology, medical device, or other regulated life sciences facilities.
- Develop, review, and execute validation documentation, including:
- Validation Plans
- User Requirements Specifications (URS)
- Risk Assessments
- Design/Functional Specifications
- Commissioning documentation
- IQ/OQ/PQ protocols and reports
- Traceability Matrices
- Summary Reports
- Support qualification of equipment, facilities, utilities, and manufacturing systems.
- Perform protocol execution, field verification, data collection, and review of qualification results.
- Ensure validation activities are performed in compliance with GMP, FDA, EU GMP, and applicable industry standards.
- Participate in FMEA/risk assessments and apply a risk-based approach to validation activities.
- Support deviations, investigations, CAPA, and change control activities associated with validation projects.
- Review engineering and technical documentation to ensure validation requirements are adequately addressed.
- Collaborate with Engineering, Quality Assurance, Manufacturing, Automation, Facilities, and other project stakeholders.
- Track validation deliverables, schedules, open items, and project milestones.
- Support commissioning activities and transition from commissioning into formal qualification.
- Ensure validation documentation is complete, accurate, and audit-ready.
- Participate in client meetings, project status meetings, and technical reviews.
- Provide technical support during regulatory or client inspections, as required.
CQV Experience
Candidates should have hands-on experience with some combination of:
- Commissioning and qualification of process equipment
- Facility and utility qualification
- Cleanrooms and controlled environments
- HVAC systems
- Purified Water / WFI systems
- Compressed gases and process gases
- Autoclaves, sterilizers, and/or depyrogenation equipment
- Manufacturing and laboratory equipment
- Temperature-controlled systems
- Process systems and supporting utilities
- Equipment and system turnover documentation
- IQ/OQ/PQ execution
Required Qualifications
- Bachelor's degree in Engineering, Science, or a related technical discipline.
- 3+ years of validation, qualification, commissioning, or CQV experience within a regulated life sciences environment.
- Experience working in pharmaceutical, biotechnology, medical device, or other GMP-regulated industries.
- Strong understanding of GMP and validation principles.
- Experience developing and/or executing validation and qualification protocols.
- Experience with risk-based validation methodologies.
- Strong technical writing and documentation skills.
- Ability to interpret engineering drawings, specifications, procedures, and technical documentation.
- Strong organizational and project management skills.
- Ability to work independently and collaboratively in a project environment.
