SR CQV Engineer - Spark Life Solutions Inc
Plano, TX 75074
About the Job
Roles & Responsibilities:
- Develop and execute commissioning and qualification protocols (IQ, OQ, PQ) for pharmaceutical equipment and systems.
- Perform risk assessments to determine the critical aspects of systems and processes.
- Ensure compliance with regulatory requirements and industry standards (e.g., FDA, EMA, cGMP, ICH).
- Conduct system impact assessments and generate reports to summarize the qualification status.
- Lead validation activities for new and existing processes, equipment, and utilities.
- Collaborate with cross-functional teams, including R&D, QA/QC, Manufacturing, and Engineering, to ensure validation deliverables are met.
- Develop validation master plans, protocols, and reports for systems, facilities, and processes.
- Troubleshoot and resolve validation issues, deviations, and discrepancies.
- Prepare detailed validation documentation, including protocols, test scripts, and reports.
- Maintain up-to-date knowledge of industry trends, regulatory changes, and best practices.
- Ensure all validation activities comply with internal SOPs and external regulatory guidelines.
- Support audits and inspections by regulatory authorities and internal quality assurance.
- Coordinate and manage CQV projects from initiation to completion, ensuring timelines and budgets are met.
- Develop project schedules and track progress against milestones.
- Communicate effectively with stakeholders and provide regular updates on project status.
- Identify and mitigate risks associated with CQV activities.
- Identify opportunities for process improvement and optimization in CQV activities.
- Implement best practices and innovative solutions to enhance efficiency and effectiveness.
- Train and mentor junior engineers and technicians in CQV methodologies and practices.
Education & Experience:
- Bachelor's or Master's degree in Engineering (Chemical, Mechanical, Biomedical, or related field).
- Minimum of 5-7 years of experience in CQV within the pharmaceutical or biotechnology industry.
- Proven experience with commissioning and qualification of equipment such as bioreactors, chromatography systems, and HVAC systems.
- Experience in cleanroom environments and understanding of contamination control measures.
- Strong understanding of regulatory requirements (FDA, EMA, ICH, cGMP).
- Proficiency in developing and executing IQ/OQ/PQ protocols.
- Familiarity with computerized systems validation (CSV) and Part 11 compliance.
- Knowledge of risk assessment tools and methodologies.
Source : Spark Life Solutions Inc