Principal/Senior Specialist, CSVC

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.

Duties & Responsibilities

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 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.

Sr. Specialist

• Identifies and implements Computerized System Validation and Compliance (CVSC) procedures and improvements within the department and across the organization.

• Supports established CSV objectives and commitments to improve consistency across the system validation portfolio.

• Performs assigned CSVC activities based on company and regulatory requirements.

• Communicates to appropriate stakeholders regarding execution of the validation process.

• Supports CSVC training within the department and/or across the site.

• Supports CSVC projects through the assimilation of data, establishing facts and drawing valid conclusions to deliver results in accordance with resources, constraints and business needs.

• Delivers project results based on business needs.

• Provides expertise for critical quality and compliance GxP end-use applications supporting Animal Health business processes.

Requirements

Principal Specialist

• Bachelor of Science in Engineering, Information Technology, Chemistry or related Science/Technology degree.

• In addition to Bachelor's degree in related scientific/technology field, position requires a minimum of six (6) years of relevant CSVC experience in a cGMP organization or similar manufacturing environment.

OR

• Master’s degree in a related scientific/technology field, position requires a four (4) years relevant CSVC experience in a cGMP organization or similar manufacturing environment.

OR

• In lieu of degree, a minimum of twelve (12) years of 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.

• 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.

Sr. Specialist

• Bachelor of Science in Engineering, Information Technology, Chemistry or related Science/Technology degree.

• In addition to Bachelor's degree in related scientific/technology field, position requires a minimum of four (4) years of relevant CSVC experience in a cGMP organization or similar manufacturing environment.

OR

• Master’s degree in a related scientific/technology field, position requires a two (2) years relevant CSVC experience in a cGMP organization or similar manufacturing environment.

OR

• In lieu of degree, a minimum of eight (8) years of 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 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.

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.

Desired Skills, Experience and Abilities

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.