JOB SUMMARY
The incumbent is responsible for leading computerized systems validation projects. This includes qualification of GxP computerized systems for both laboratory and manufacturing based equipment as well as GMP software applications. Key deliverables are preparation of relevant documentation to meet regulatory requirements for new and existing products (Validation Plans, User Requirements Specifications (URS), Risk Assessments, IQ/OQ/PQ protocols and Traceability Matrices). Collaborate with cross functional teams, ensure compliance with regulatory requirements, and drive bestinclass validation practices that support our Quality Management System and operational excellence.ย
ESSENTIAL JOB FUNCTIONS
- Lead Protocol generation, oversee execution, data analysis, report generation and approval of qualification activities for GMP software applications
- Review and approve qualification documentation on behalf of the validation function
- Evaluate, audit, and guide software validation activities to ensureย compliance with FDA, ISO, Data Integrity guidance, and internal standards
- Support investigations into protocol nonconformances and site deviations
- Serve as initiator and owner of validation related change controls and corrective and preventative actions
- Author standard operating procedures related to CSV validationย practices
- Support the execution and generation of formal risk assessments
- Enhance CSV validation programs
- Analyze validation data, identify gaps, and support investigations andย corrective actions
- Represent CSV during audits and regulatory inspections
SPECIAL WORK REQUIREMENTS
- Fully onsite position
- Strong communication skills
- Familiarity with Microsoft Office, Excel, and Visio
- Ability to work well with diverse groups in a matrix-style, growing, safety focused organization
- Ability to manage multiple activities
- The ability to communicate with fellow project team members
- Criminal background check required
- Other duties as assigned
EDUCATION/CERTIFCATIONS/LICENSES
A minimum of a Bachelor's degree in Engineering, Computer
Science or related discipline
Desired
ON-THE-JOB EXPERIENCE
7+ years of Computer System Validation experience ย
Desired
KNOWLEDGE, SKILLS AND EXPERIENCE
In depth CSV experiences including as a Validation lead
Essential
The ability to communicate with employees of all experience levels from Genezen and other contract firms
Essential
The ability to report on project activity in a clear and concise manner
Essential
The ability to communicate with fellow project team members
Essential
Understanding of cGMP regulations
Essential
Technical writing ability
Essential
Familiarity with Microsoft Office
Essential
Ability to work well with diverse groups in a matrix-style, growing, safety focused organization
Essential
Ability to manage multiple activities with challenging timelines
Essential
In depth knowledge of 21 CFR Part 11, EU GMP Annex 11 and GAMP5 computerized system
Essential
Pay Range:
The annual salary range for this position based upon level hired is: $115,000 - $140,000
Work Environment
- Regularly sit for extended periods of time
Movement
- Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and armsย
- 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-mailย ย ย ย