- Responsible for planning, scheduling, execution and leading validation project assignments in coordination with the IT Manager and in accordance with Good Laboratory Practices (GLPs) and FDA 21 CFR Part 11.
- Validation assignments include validation, qualification, and implementation of new and existing, processes, equipment, software, and instrumentation systems.
- Leads cross-functional project teams in the development and implementation of the validation plan and protocols.
- Prioritizes, manages and executes multiple projects utilizing Project Management methodology. This may include assignment/oversight/review of validation projects to other personnel/teams.
- Review and approve all validation documentation (plans, protocols, summary reports, etc), including vendor documentation.
- Acts as the primary Validation contact source for vendors, the FDA, and sponsors. Provides support for regulatory submissions and regulatory agency inspections as required.
- Responsible for maintaining and updating XBL’s Validation Master Plan (VMP).
- Maintains a thorough knowledge of the organization, policies and Standard Operating Procedures (SOPs), adheres to all organizational standards defined in SOPs and the XBL Employee Handbook, and coordinates with IT team activities.
- Support development of best demonstrated validation practices within the IT department, based on current industry practices and guidelines.
- Champions continuous improvement of XBL’s practices, documentation, forms, SOPs, and systems within the IT department (including validation) and throughout XBL.
- Serve on XBL’s SOP Committee, Review/Harmonize SOPs, and author assigned SOPs to ensure compliance with Company policies and federal regulations.
- Provides Business Support/Training to Users for Thermo Scientific’s Watson LIMS System and other Validated Systems as assigned.
- Other duties as assigned.
- Bachelor’s degree applicable to a pharmaceutical R&D environment.
- Minimum of 5 years experience in a regulated, GxP environment validating and qualifying laboratory equipment, computer systems, and processes.
- Extensive, in-depth knowledge and understanding of Good Laboratory Practices (GLP) and quality requirements in an FDA-regulated environment along with knowledge of 21 CFR Part 11.
- Exceptional written and verbal communication skills with superior organizational skills.
- Excellent problem solving skills and the ability to quickly and effectively analyze critical issues and develop assessments for risk and impact.
- Ability to utilize Project Management methodologies to manage validation projects.
- Ability to work in a high pressure, fast-paced, environment.
- Ability to work with various scientists and management across various departmental groups to achieve company’s goals and objectives.
- Ability to work independently and manage time with respect to project priorities.
- Have thorough understanding of the Bioanalytical Process.
- Ability to operate instrumentation within the limits required for validation development and execution, with the appropriate training provided by XBL staff or the vendor if required.
- Advanced knowledge and experience of complete MS Office system.
- Firm understanding of all associated technology platforms as needed for validation projects.
- Ability to effectively manage other Laboratory Informatics Systems as assigned
Job Function: Research & Development
Primary Location: Plainsboro NJ
Please contact Jennifer.Royal@wuxiapptec.com for more information about this position
If you are interested in learning more about the opportunities, please visit our website: https://careers-wuxiapptec.icims.com/jobs