Our client, a leading pharmaceutical company, is hiring a Sr. Specialist, Project Leader on a contract basis.
Education and Experience
• Bachelors degree in a related field from an accredited college or university required.
• Minimum of 3 years relevant work experience required, preferably in the pharmaceutical, biotechnology, or cell therapy manufacturing industry.
• Strong project management and/or change management skills are helpful. Minimum of 1 year of experience with project coordination and cross-functional team leadership preferred.
• Minimum of 1 year of experience with the execution of electronic batch records required, experience supporting electronic batch record creation and testing preferred, preferably Syncade MES.
• Knowledge of Delta V or other process automation software desirable; ability to use process historian and analyze data to assist troubleshooting.
• Computer System Validation (CSV) experience – creating/running test scripts helpful but not required.
DUTIES AND RESPONSIBILITIES:
• Apply manufacturing process expertise and electronic batch record technical knowledge to own electronic batch record changes and the associated change controls.
• Own Electronic Batch Record (MES/Syncade) Functional specifications. Ensure consistent execution of recipe modifications and changes. Ensure adherence with governing documents related to change management.
• Works collaboratively with Manufacturing, Digital Plant, IT, Validation, Quality, and MS&T to ensure change initiatives are driven to closure, and migrated to the production area in a timely manner.
• Owns the lifecycle of an electronic batch record change
• Works with site functional teams, including manufacturing, engineering, warehouse and quality assurance to gather user requirements for recipe development.
• Understanding of MES library objects. Use that understanding to direct changes to MES recipes and/or directly update the MES recipes utilized in Manufacturing.
• Develop documentation to support the qualification of the MES recipes, including test scripts and functional specifications.
• Execute testing of the recipes in the development environment to ensure functionality.
• Manage User Acceptance Testing process for recipe qualification.
• Provide technical support by troubleshooting and resolving MES issues to support manufacturing operations.
• Develop and deliver reports from reporting software.
• Able to use creative problem solving. Provides technical expertise to management and less experienced professionals.
• Perform other tasks as assigned.