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Job Analysis:
The CSV Engineer - GMP role is fundamentally focused on ensuring the integrity and compliance of Manufacturing Execution Systems (MES) and DeltaV control systems within a biopharmaceutical setting. This involves validating existing systems and upgrades to support the company’s commitment to excellence in quality and regulatory adherence. Primary responsibilities include writing and executing validation protocols, such as Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), alongside conducting risk assessments and maintaining thorough documentation. Success in this role will hinge on the ability to collaborate with cross-functional teams, handle intricate system functionalities, and ensure compliance with both internal standards and external regulations. The candidate will likely face challenges related to navigating the complexities of system validation and alignment with Good Manufacturing Practices (GMP), requiring a blend of technical expertise and strategic problem-solving capabilities.
Company Analysis:
Insight Global stands as a prominent player in the professional services and staffing industry, particularly known for its comprehensive approach in delivering talent solutions across various sectors, including healthcare. The company values empowerment and professional development, suggesting a culture that invests in people's growth and adaptability. Given its expansive reach with over 70 locations globally, this role as a CSV Engineer will likely involve significant collaboration across international teams and stakeholders, emphasizing the importance of teamwork and communication. The role fits within a fast-paced, results-driven environment, essential for supporting biopharmaceutical clients who are focused on maintaining regulatory compliance and operational excellence. With a strategic goal of enhancing clients' capabilities, this role is positioned to make a meaningful impact on project success and client satisfaction, further solidifying Insight Global's reputation in the market.