Senior CSVC Validation Lead

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance.

Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

The Principal Specialist, CSVC oversees all aspects of computer system and computer system and computerized equipment validation within BIAH Operations, including program implementation of corporate CSVC policies and procedures, and the approval, authoring and execution of validation deliverables to ensure GxP regulatory compliance. The incumbent leads key data integrity assessment, remediation activities as well as GxP system administration and business process analysis for relevant applications.

This role oversees Quality Assurance auditing role for computerized systems and provides technical leadership for implementation of computerized systems and CSVC projects.

Description

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance.

Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

The Principal Specialist, CSVC oversees all aspects of computer system and computer system and computerized equipment validation within BIAH Operations, including program implementation of corporate CSVC policies and procedures, and the approval, authoring and execution of validation deliverables to ensure GxP regulatory compliance. The incumbent leads key data integrity assessment, remediation activities as well as GxP system administration and business process analysis for relevant applications.

This role oversees Quality Assurance auditing role for computerized systems and provides technical leadership for implementation of computerized systems and CSVC projects.

Principal Specialist

• Independently establishes and overseas Computerized System Validation and Compliance (CVSC) procedures and improvements both within the department and across the organization through active collaboration of relevant stakeholders
• Understands content and compliance requirements for related CSV deliverables and uses this knowledge to improve consistency across the system validation portfolio
• Applies in-depth knowledge and broad application of relative practices, techniques and standards to the direction, implementation and execution of the validation process
• Develops and leads organizational goals and priorities for multiple CSVC projects through the assimilation of data, establishing facts and drawing valid conclusions to deliver results in accordance with resources, constraints and business needs
• Independently leads projects including oversight of project budget and resources/external consultants as applicable
• Establishes and shares project results, metrics, KPIs with relevant stakeholders and site leaders
• Applies knowledge and experience to a wide range of situations, potentially within multiple business areas
• Demonstrates a depth and breadth of knowledge in own discipline that is applied to a wide range of situations and regulatory requirements that, also, supports the mentoring and training of colleagues to problem resolution
• Accountable for individual contributor excellence competencies and personal performance…