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Principal/Sr. Computer System Validation Engineer

Boehringer Ingelheim

Last Updated: 11/29/22

Job Description

Description: 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. Leads key data integrity assessment, remediation activities as well as GxP system administration and business process analysis for relevant applications. Oversees Quality Assurance auditing role for computerized systems. Provides technical leadership for implementation of computerized systems and CSVC projects. 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 a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. Duties & Responsibilities: Independently establishes and oversees 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 behaviors, action plans and feedback process; drives team and area results based on business needs. Fulfills a subject matter expert role(s) for critical quality and compliance GxP end-use applications supporting Animal Health business processes. Requirements: Principal Specialist CSVC Bachelor’s degree preferred. In lieu of degree, a minimum of 12 years of professional experience in conducting computerized systems validation in pharmaceutical or vaccine manufacturing or similar regulated environment. In addition to Bachelor's degree, position requires a minimum of 8 years of relevant CSVC experience in a cGMP organization or similar manufacturing environment. In lieu of degree, position requires 12 years relevant CSVC experience in a cGMP organization or similar manufacturing environment. Relevant experience must include conducting computerized systems validation in a regulated industry such as pharmaceutical or vaccine operations. Relevant experience must include effectively leading moderate to complex projects. Thorough understanding of computerized system validation requirements for GxP systems as expressed by the FDA, EU or other regulatory agencies with special focus on EU Annex 11, 21 CFR Part 11 and Data Integrity. Strong theoretical knowledge, practical knowledge and application of computerized systems, programming, relational databases and information technology. Knowledge of GAMP and other approaches to System Development Life Cycles (SDLC). Excellence in comprehension, theoretical knowledge, practical knowledge and application of FDA, USDA and EU regulatory requirements for the production and distribution of pharmaceutical and vaccine regulated articles. Demonstrated ability to work and lead in a team environment. Attention to detail and strong analytical skills. Excellent communication skills, both written and verbal. Ability to work well with people at various levels and with different cultural backgrounds. Sr. Specialist CSV Requirements: Bachelor's degree preferred. In lieu of degree, a minimum of 8 years of professional experience in conducting computerized systems validation in pharmaceutical or vaccine manufacturing or similar regulated environment. In addition to Bachelor's degree, position requires a minimum of 4 years of relevant CSVC experience in a cGMP organization or similar manufacturing environment. In lieu of a degree, position requires 8 years relevant CSVC experience in a cGMP organization or similar manufacturing environment. Relevant experience must include conducting computerized systems validation in a regulated industry such as pharmaceutical or vaccine operations. Relevant experience must include effectively supporting moderate to complex projects. Understanding of computerized system validation requirements for GxP systems as expressed by the FDA, EU or other regulatory agencies with special focus on EU Annex 11, 21 CFR Part 11 and Data Integrity. Theoretical knowledge, practical knowledge and application of computerized systems, programming, relational databases and information technology. Knowledge of GAMP and other approaches to System Development Life Cycles (SDLC). Competent in comprehension, theoretical knowledge, practical knowledge and application of FDA, USDA and EU regulatory requirements for the production and distribution of pharmaceutical and vaccine regulated articles. Demonstrated ability to work and lead in a team environment. Attention to detail and strong analytical skills. Excellent communication skills, both written and verbal. Ability to work well with people at various levels and with different cultural backgrounds Eligibility Requirements: Must be legally authorized to work in the United States without restriction. Must be willing to take a drug test and post-offer physical (if required). Must be 18 years of age or older. Who We Are: At Boehringer Ingelheim we create value through innovation with one clear goal: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company we focus on long term performance. We are powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive culture. Learning and development for all employees is key because your growth is our growth. Want to learn more? Visit boehringer-ingelheim.com and join us in our effort to make more health. Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities. All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law. #LI-MS1 #PDN2 *I-SF1



Company Details

Binger Strasse, Germany