Bayer Bayer Animal Health Computer System Validation Specialist in Shawnee Mission, Kansas

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Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life.

At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.

Apply online

Bayer Animal Health Computer System Validation Specialist

Your tasks and responsibilities

The primary responsibilities of this role, Bayer Animal Health Computer System Validation Specialist, are to:

Who you are

  • Analyses, Acceptance Criteria, Traceability Matrix, and Validation Summary Reports;

  • Facilitate the Computer system Validation Risk Assessment to identify governing regulations and validation deliverables during the development of computerized systems that support GxP activities.

  • Assess vendor provided validation packages and develop a validation strategy by aligning it with the site Computer Validation Master Plan;

  • Review proposed changes to validated systems and identify the validation requirement necessary to maintain the systems’ validated state;

  • Completion of all required computer system validation tasks as per the required project timelines;

  • Develop knowledge and skills as subject matter expert on computer validation lifecycle process;

  • Support Regulatory inspections and internal and partner audits, and implement corrective actions as needed;

  • Provide training to colleagues and contractors on site Computer System Validation Standard Operating Procedures;

  • Assist cross-functional teams in planning, implementing, and documenting user acceptance testing of software.


Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:

Required Qualifications:

  • Bachelor’s Degree in Computer Science or Management Information Systems, Computer Information Systems, or a related field;

  • A minimum of five years’ computer system validation experience;

  • Experience with the management, development and/or validation of Information Systems Technology projects is preferred. This experience may include but is not limited to the following: TrackWise, SAP/ERP, SharePoint, Oracle, SQL, Manufacturing Execution Systems, LIMS, LIS, software quality testing in GMP and/or GLP environment;

  • Knowledge of cGMP regulations and guidelines including but not limited to U.S. Code of Federal Regulations 21 CFR Part 11 and Part 211, EudraLex Volume 4 and Annex 11, and ICH Q7, Q8, Q9 and Q10;

  • Thorough understanding of risk based validation lifecycle for computerized systems and best practices such as GAMP 5;

  • Excellent communications skills (oral and written). Ability to understand and develop process maps;

  • Familiarity with V model and other approaches to System Development Life Cycle (SDLC) validation;

  • Proven ability to work independently with strong technical writing;

  • Proven ability to define problems, collect data, establish facts, and draw valid conclusions from these observations;

  • Self-starter and motivated to provide a solid product quality and customer experience.

Preferred Qualifications:

  • Prior experience in working with Current Good Manufacturing Practices and/or Good Laboratory Practices, and Quality Systems is preferred.

Your application

Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.

Bayer is an Equal Opportunity Employer/Disabled/Veterans

Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.

Country:United States

Location:KS-Shawnee Mission