JOB SUMMARY

The incumbent is responsible for leading computerized systems validation projects and supporting the data integrity program. This includes qualification of GxP computerized systems for both laboratory and manufacturing based equipment as well as GxP software applications. Key deliverables are preparation of relevant documentation (Validation Plans, User Requirements Specifications (URS), Risk Assessments, IQ/OQ/PQ protocols and Traceability Matrices) to meet regulatory requirements for new and existing products. Collaborates with cross functional teams, ensuring compliance with regulatory requirements, and drives best-in-class validation practices that support our Quality Management System and operational excellence.

JOB RESPONSIBILITIES

• Lead risk-based validation strategies for GxP computerized systems throughout the system lifecycle including protocol generation, oversee execution, data analysis, report generation and approval of qualification activities for GxP software applications
• Review and approve qualification documentation on behalf of the validation function
• Evaluate, audit, and guide software validation activities to ensure compliance with FDA, EU, ISO, Data Integrity guidances, and internal procedures and standards
• Assess the impact of system-related events on the system's validated state and data reliability.
• Lead validation execution and ensure testing is appropriately documented
• Support quality events involving CSV in protocol nonconformances, deviations, investigations, CAPAs, and change controls. Serve as initiator and owner of validation related change controls and corrective and preventative actions
• Develop, author and improve CSV procedures, templates, standards, and guidance. Monitor industry and regulatory trends and recommend improvements to company practices
• Support the execution and generation of formal risk assessments
• Support and conduct periodic reviews
• Support the evaluation of data lifecycles and data flow from creation through processing, review, approval, reporting, retention, and archival
• Support risk-based Data Integrity Assessments and the audit trail review process
• Identify data integrity risks and partner with system owners to implement remediation plans
• Provide CSV and Data Integrity expertise during vendor selection and qualification. Define expectations for vendor testing, validation documentation, audit trails, electronic signatures, and data retention.
• Provide guidance to project teams, system owners, IT, and vendors regarding GxP validation requirements
• Promote a strong data integrity culture across GxP functions
• Support audits and regulatory inspections in representing CSV, as needed

SPECIAL JOB REQUIREMENTS

• Adaptability required as work schedule may change based on business needs
• Criminal background check required
• Other duties as assigned

EDUCATION / CERTIFICATIONS / LICENSES

• A minimum of a bachelor's degree in Engineering, Computer Science or related discipline

ON-THE-JOB EXPERIENCE

• 7+ years of Computer System Validation experience
• Strong understanding of GxP computerized systems and validation principles with experience leading validation projects for Enterprise, Laboratory, Manufacturing, and Quality Systems.
• Demonstrated experience developing and executing risk-based CSV strategies
• Experience with computerized system periodic reviews
• Experience with audit trail and data integrity assessments

SKILLS / ABILITIES

• The ability to communicate effectively with employees of all experience levels from Genezen and other contract firms
• The ability to report on project activity in a clear and concise manner
• The ability to communicate and work effectively with fellow project team members
• Ability to work well with diverse groups in a matrix-style, growing, safety focused organization
• Understanding of cGMP regulations
• Strong technical writing skills
• Strong working knowledge in Microsoft Office (Word, Excel, Visio, etc.) and Adobe Acrobat
• Strong project management skills with the ability to manage multiple activities with challenging timelines
• Strong working knowledge of 21 CFR Part 11, EU GMP Annex 11, ICH guidelines, GAMP 5 and data integrity guidelines

COMPENSATION RANGE

The anticipated annual salary range for the Sr. Validation CSV positions is $115,000-$140,000.

PHYSICAL DEMANDS

While performing the duties of this job, the employee is required to meet the following physical demands:

Work Environment

• Regularly sit for long periods of time.

Movement

• Frequently required to stand; sit; walk; balance; stoop; kneel; crouch; use hands to finger, handle, or feel; reach with hands and arms
• Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl

Lifting

• Frequently lift and/or move up to 10 pounds
• Rarely lift and/or move up to 25 pounds

Vision

• Frequently utilize close vision and the ability to adjust focus

Communication

• Frequently required to communicate by talking, hearing, using telephone and e-mail

Genezen has operates two locations: one in Fishers, Indiana and the second in Lexington, Massachusetts.

Fishers is a suburb of Indianapolis. Fishers was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing art community and the world's largest children's museum--to name just a few reasons why this area is a great place to live.

Lexington, Massachusetts, located just northwest of Boston, is renowned as a historic suburb with a rich cultural heritage. It boasts picturesque New England charm, tree-lined streets, and a vibrant community. Known for its pivotal role in the American Revolution, Lexington offers visitors and residents alike a blend of historical landmarks, modern amenities, and a strong sense of community pride.