What are the responsibilities and job description for the Validation Engineer position at Cogent Biopharma?
Key Responsibilities:
- Develop, review, and execute commissioning, qualification, and validation protocols (IQ, OQ, PQ) for equipment, facilities, and computerized systems.
- Collaborate closely with Manufacturing, Engineering, Quality Control (QC), and Quality Assurance (QA) teams to ensure validation activities are aligned with project timelines and regulatory requirements.
- Lead the development and validation of cleaning cycles, including conducting sprayball coverage testing, visual inspections, and drafting standard operating procedures (SOPs).
- Manage and provide guidance to validation contract staff to ensure timely completion of assigned tasks and adherence to quality standards.
- Conduct comprehensive risk assessments and validation planning for both new and existing systems to mitigate potential issues.
- Perform root cause analysis for validation-related incidents, deviations, and troubleshooting activities to drive continuous improvement.
- Address and resolve Corrective and Preventive Actions (CAPAs), non-conformances, protocol incidents, and change controls related to validation activities.
- Support validation periodic monitoring and re-qualification programs to maintain compliance with regulatory standards.
- Assist during audits related to validation processes, providing necessary documentation and support.
Qualifications & Skills:
- Education: Bachelor's or Master’s degree in Engineering, Life Sciences, or a related field.
- Experience: Minimum of 4 years in a GMP-regulated environment, specializing in equipment and cleaning validation.
- Thorough understanding of system validation life-cycle concepts with demonstrated experience in capital projects within pharmaceutical manufacturing.
- Hands-on expertise in pharmaceutical manufacturing processes, equipment, and quality systems.
- Proficiency in cGMP regulations, international guidelines, and 21 CFR Part 11 compliance.
- Technical proficiency in Cleaning Development & Cleaning Validation methodologies.
- Experience with computer system validation, data integrity practices, and regulatory compliance requirements.
- Strong analytical, problem-solving, project management, and technical writing skills.
- Ability to effectively lead validation projects, manage multiple tasks concurrently, and collaborate seamlessly within cross-functional teams.
Benefits:
- Competitive salary commensurate with experience.
- Comprehensive benefits package including health insurance, retirement plans, and professional development opportunities.
- Opportunity to contribute to cutting-edge projects in a state-of-the-art manufacturing facility.
- Dynamic work environment with potential for career growth and advancement.
