Computer System Validation Lead

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There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

Computer System Validation Lead

Computer System Validation Lead Indianola, PA

Purpose :

Candidate will be responsible for leading and managing the computer system validation activities and supporting offshore teammates to ensure R&D software systems are compliant with regulatory requirements and industry standards.

The Computer System Validation Lead will work closely with cross-functional teams to ensure the successful validation of computer systems used in the pharmaceutical or medical device industries

YOUR TASKS AND RESPONSIBILITIES

• Develop and maintain computer system validation strategies, plans, protocols, and reports in compliance with regulatory guidelines and industry standards;
• Plan, lead and manage the validation activities for computer systems, including but not limited to, systems such as Atlassian Suite (Jira, Confluence, Crowd) IBM ELM Suite, GitHub, JFrog Artifactory, Static Analysis Tools, Scripting Tools, and legacy build tools Integrity MKS,
• Jenkins;
• Collaborate with cross-functional teams to ensure that computer systems are implemented, validated, and maintained in accordance with regulatory requirements and company policies;
• Provide oversight, guidance, and support regarding system administration, knowledge transfer, validation activities, including risk assessments, requirements gathering, testing, and documentation, while overseeing and upskilling offshore CSV teammates performing
• similar efforts;
• Review and / or develop validation documentation, including validation plans, user requirements specifications, functional specifications, and test scripts;
• routing required documentation for approval as required;
• Conduct and oversee periodic system reviews and audits of computer systems to ensure ongoing compliance with regulatory requirements and industry standards;
• Develop and maintain a knowledge base for system administrators, including guidance for CSV activities;
• Manage the backlog of all requests and run team meetings to keep sprints and / or tickets on track towards timely closure;
• Serve in the role of System Administrator for the various software systems in scope, including addressing user access requests;
• Develop and distribute user communications regarding systems, e.g. outages, issues, improvements, etc.;
• Maintain systems documentation, including developing and maintaining user training materials;
• Stay current with industry trends and regulatory changes related to computer system validation and provide recommendations for continuous improvement.

WHO YOU ARE

Bayer seeks an incumbent who possesses the following :

REQUIRED QUALIFICATIONS

• Bachelor's or Master’s degree in Computer Science, Business, Engineering, or related field;
• Experience in computer system validation within the pharmaceutical or medical device industries;
• Knowledge of regulatory requirements, including FDA 21 CFR Part 11, GAMP 5, and other relevant guidelines;
• Strong understanding of validation principles, methodologies, and best practices;
• Excellent project management and leadership skills;
• Effective communication and interpersonal skills, with the ability to work collaboratively in a cross-functional environment.

PREFERRED QUALIFICATIONS

• Certification in computer system validation (e.g., CSV, CSQE).
30+ days ago