Summary :We are seeking a Validation Engineer II to support critical validation activities within a pharmaceutical / biopharmaceutical manufacturing environment. The ideal candidate will have hands-on experience in Commissioning, Qualification, and Validation (CQV), including the development and execution of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for equipment, utilities, facilities, and Controlled Temperature Units.
Roles and Responsibilities : - Develop, review, and execute CQV deliverables for pharmaceutical and biopharmaceutical systems.
- Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for equipment, utilities, facilities, and controlled temperature units.
- Lead and support temperature mapping studies for controlled temperature units and temperature-controlled environments.
- Ensure validation activities comply with cGMP requirements, ICH guidelines, and FDA regulations.
- Analyze validation data, identify trends, and ensure results meet established acceptance criteria.
- Investigate validation deviations and support root cause analysis and corrective actions.
- Develop, track, and implement Corrective and Preventive Actions (CAPAs).
- Manage change controls for validated systems and assess their impact on qualification status.
- Prepare validation protocols, reports, and other CQV documentation.
- Support internal and external audits by preparing validation records and presenting validation activities when required.
- Collaborate with Manufacturing, QA, Engineering, and R&D teams to ensure successful validation execution.
- Maintain accurate and compliant validation documentation in accordance with company procedures.
- Support continuous improvement of validation processes and maintain the validated state of systems.
Education & Experience : - Bachelor's degree in Chemical Engineering, Biomedical Engineering, Mechanical Engineering, or a related scientific discipline.
- 2-6 years of validation engineering experience.
- Experience in the pharmaceutical or biopharmaceutical industry.
- Hands-on experience developing and executing CQV deliverables.
- Strong experience with IQ, OQ, and PQ protocols and execution.
- Experience validating equipment, utilities, facilities, and controlled temperature units.
- Temperature mapping experience is highly preferred.
- Knowledge of cGMP requirements and ICH guidelines.
- Understanding of FDA regulations, including 21 CFR Parts 210, 211, and 820.
- Experience with validation data analysis and deviation handling.
- Familiarity with CAPA and change control processes.
- Experience supporting internal and external audits.
- Strong cross-functional communication and coordination skills.
