Our client, a leading pharmaceutical company, is hiring a Sr. Specialist, Project Manager on a contract basis.
Work Location
Devens, MA
Summary
The Sr. Specialist provides input to the design and recipe development for manufacturing electronic batch records (MES). The Sr. Specialist works with Digital Plant, IT, Manufacturing Operations and process subject matter experts to deliver changes to MES recipes. The position requires excellent project management skills and coordination with stakeholders. The Sr. Specialist reports to the Sr. Manager Manufacturing Project Leads, Cell Therapy Manufacturing Technology.
REQUIRED SKILLS
• Bachelors degree in a related field from an accredited college or university required.
• Minimum of 4 years relevant work experience required, preferably in the pharmaceutical, biotechnology, or cell therapy manufacturing industry.
• Strong project 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 supporting electronic batch records, 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
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.
• More than 1-2 years GMP, Cell Therapy, manufacturing experience or process engineering, efficient in using MES batch records.
• Project management experience is secondary, not the focus