Computer System Validation Csv Remote Jobs in Indiana

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Manages the development, implementation and maintenance of software applications. Develops project plans, and time and cost estimates. Provides direction and leadership to a team of applications developers including the scheduling, assignment, and review of project work. Tracks, monitors, and communicates project progress against the project plan and key milestones. Likely to be actively involved in the execution of the technically complex aspects of projects.

RESPONSIBILITIES

• Lead, coach, and develop a team of application analystsresponsible for supporting and administering healthcare applications, ensuring high performance, accountability, and alignment with GMP compliance requirements.
• Oversee the full lifecycle support of GMP applications, including Computerized System Validation (CSV), system maintenance, troubleshooting, and ensuring systems remain compliant with regulatory standards.
• Serve as a global project manager for GMP-related IT initiatives, leading complex, cross-site projects that impact multiple healthcare locations and ensuring successful execution from planning through completion.
• Manage project scope, timelines, budgets, and risks, proactively identifying potential barriers, resolving issues, and ensuring projects are delivered on time and within cost expectations.
• Partner with cross-functional business teamsto assess operational needs, gather requirements, and identify opportunities to improve or implement IT solutions that enhance efficiency and performance.
• Ensure all IT solutions align with GMP regulations and internal standards, maintaining compliance while supporting business objectives and long-term strategic goals.
• Act as a key liaison between stakeholders, including QA, IT, business users, and external partners, balancing priorities and ensuring clear, effective communication across all groups.
• Collaborate with internal IT teams and external vendorsto troubleshoot technical issues, implement system enhancements, and ensure reliable performance of GMP applications.
• Contribute to leadership activities, including setting departmental goals, supporting personnel decisions, and helping define and execute the organization's digitalization and IT strategy.
• Maintain strict adherence to cGMP, quality, and ESHS standards, ensuring proper documentation, safety practices, training compliance, and immediate reporting of any risks impacting product quality or workplace safety.

REQUIREMENTS

• Bachelor's degree in Computer Science (or equivalent) with 10+ years of relevant professional experience.
• Strong background in application development or system administration, with broad knowledge of software and hardware systems.
• Proven experience leading complex projects and cross-functional teamsacross multiple stakeholders.
• Advanced knowledge of GxP and GAMP Computer System Validation (CSV)in regulated environments.
• Strong critical thinking, problem-solving, and decision-making skillsin technical and business scenarios.
• Experience with risk assessment, business impact analysis, and continuity planning, including identifying vulnerabilities and controls.
• Excellent communication and documentation skills, with the ability to prioritize work, collaborate across cultures, and travel as needed.

The Evonik Group adopts an Equal Employment Opportunity (EEO) approach. Candidates are assessed based on their educational qualifications, experience, job competencies and potential and shall not be discriminated against on the basis of race, ethnicity, age, gender, religion, nationality, disability or sexual orientation or other classifications protected by local, state, or provincial regulations.

Your Application

To ensure that your application is proceeded as quickly as possible and to protect the environment, please apply online via ourcareersportal. Further information about Evonik as Employer can be found at https://careers.evonik.com.

Please address your application to the Talent Acquisition Manager, statingyour earliest possible starting date and your salary expectations.

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