Boehringer Ingelheim Pharmaceuticals, Inc

Principal/Senior Specialist, CSVC

Boehringer Ingelheim Pharmaceuticals, Inc • $100K — $130K *
Saint Joseph, MI 49085In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
More than 3 months ago
Job Overview by Ladders

Qualifications

  • Bachelor's or Master's degree in Engineering, Information Technology, Chemistry or related field.
  • 6+ years of relevant CSVC experience in cGMP or similar environments (or equivalent experience).
  • Strong understanding of GxP system requirements including FDA and EU regulations.
  • Thorough knowledge of computerized systems validation practices and techniques.
  • Excellent analytical skills with attention to detail.

Responsibilities

  • Oversee Computerized System Validation and Compliance (CVSC) procedures, driving improvements across the organization.
  • Ensure consistency in CSV deliverables through in-depth understanding of content and compliance requirements.
  • Lead multiple CSVC projects, setting organizational goals and priorities based on data analysis.
  • Manage project budgets and resources, including external consultants when necessary.
  • Communicate project results and metrics to stakeholders, ensuring alignment with business needs.
  • Mentor colleagues, applying knowledge to aid in problem resolution and training efforts.
  • Function as a subject matter expert for GxP end-use applications related to Animal Health.

Benefits

  • Opportunities for professional growth and development.
  • Collaborative work environment with active stakeholder engagement.
  • Involvement in cross-functional projects that impact the organization.
  • Access to advanced resources and technologies to improve competency.
  • Commitment to compliance and quality in the operations support.
Full Job Description
Description

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

About Boehringer Ingelheim Pharmaceuticals, Inc

Boehringer Ingelheim Pharmaceuticals, Inc. is a research-driven pharmaceutical company that discovers, develops, and manufactures prescription medicines. The company's mission is to improve the health and quality of life of patients by developing innovative therapies. Boehringer Ingelheim Pharmaceuticals, Inc. is a subsidiary of Boehringer Ingelheim Corporation, which is headquartered in Ingelheim, Germany. The company's research and development efforts focus on respiratory diseases, immunology, oncology, and diseases of the central nervous system. Boehringer Ingelheim Pharmaceuticals, Inc. was founded in 1885 and is based in Ridgefield, Connecticut.
Learn more about Boehringer Ingelheim Pharmaceuticals, Inc
Size
5,000 employees
Industry
Pharmaceuticals & Biotech
* Ladders Estimates

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