Bayer Bayer Animal Health Senior Computer Systems Validation and Data Integrity Specialist in Shawnee Mission, Kansas
Your tasks and responsibilities
The primary responsibilities of this role, Bayer Animal Health Senior Computer Systems Validation and Data Integrity Specialist, are to:
Assesses BAH PS’s computer systems and identifies any potential Part 11 or Annex 11 gaps and ensures that the best CSV and DI practices are enforced;
Maintain awareness of Bayer global and site directives/policies/procedures and applicable external regulations to ensure business processes meet compliance requirements;
Development and execution of all applicable system life cycle deliverables using knowledge of all pertinent industry best practices (e.g., ISPE GAMP). Applicable system life cycle deliverables include URS, SRS, FRS, DDS, RTM, Unit, Integration, User Acceptance testing, FAT, SAT, CSV Risk Assessment, Test Plans, Test Summary Reports, Test Scripts, Data Migration Plans/Reports, Part 11 Gap Analyses, Acceptance Criteria, Traceability Matrix, Validation Planning, IQ, OQ, PQ, Final Validation Summary Report;
Who you are
Completion of all required CSV and DI tasks as per the required project timelines;
Supports and leads regulatory inspections and internal and partner audits as the CSV and DI subject matter expert, and implements corrective actions as needed in a timely manner;
Provides training to colleagues in regard to site CSV and DI SOP’s. Assists cross-functional teams in planning, implementing, and documenting all CSV and DI related software and documents;
Provide support to management to prepare, maintain and achieve the OPEX and CAPEX budgets.
WHO YOU ARE
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:
Bachelor’s Degree plus eight to ten years’ experience;
Degree in Computer Science or Management Information Systems, Computer Information Systems, or a related field;
Proven industry experience in IT Validation, Computer Systems Validation, Data Integrity, Equipment Software Validation in the Pharmaceutical or Biotechnology industry;
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, Inpstrack, WonderWare, BAS, software quality testing in GMP and/or GLP environment;
Detailed knowledge of software development lifecycle, business process management, project management concepts, best practices and related polices;
Demonstrated ability to work in a global matrix organization model and interact effectively and develop consensus with all levels of management within a multi-functional environment;
Extensive knowledge of the GMP and regulatory expectations for CSV and DI with detailed knowledge of 21 CFR Part 11, 21 CFR part 820, EU Annex 11 and GAMP;
Must be innovative, persistent and committed to a successful completion of assignments on-time with complete accuracy;
This position requires exceptional communication, team player, organizational and interpersonal skills.
- Masters’ Degree in Computer Science or Management Information Systems, Computer Information Systems or related field.
This role will be based in the Shawnee, Kansas Bayer Animal Health facility. Domestic Relocation assistance is offered for this position.
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.