Engineering - Process Engineer

Bristol Myers Squibb; Harvard (MA); On-site; USD 75,000 - 110,000; Full time

Job summary

Bristol Myers Squibb in Cambridge, MA seeks a data analytics professional to support product robustness for the commercial biologics portfolio across client and third-party sites.

You will lead Continued Process Verification activities, support SPC documentation, maintain analytics systems, perform data entry and management, and collaborate across departments to ensure data integrity and regulatory compliance.

Qualifications

• Experience with Continued Process Verification (CPV) programs.
• Knowledge of SOPs and cGMPs in a regulatory environment.
• Excellent verbal and written communication, with ability to interface across levels.

Responsibilities

• Provide support to maintain the product/site Statistical Process Control (SPC) program, manufacturing performance trending and reporting
• Manage and support investigations as a result of robustness events and SPC trending
• Provide system administration/maintenance of the Discoverant system
• Manipulate existing data files, edit information that has previously been compiled, proofread new entries within the database for accuracy
• Create forms/pages for data entry as required and data mine completed Manufacturing Batch Records
• Compile, sort and verify accuracy of data to be entered and compare data entered against source documents

Skills

Statistical analysis

Data management

SOPs & cGMPs

Communication

Leadership

Regulatory compliance

Regulatory documentation

Education

Bachelor's degree in Chemistry, Chemical Engineering, Biomedical Science or equivalent

Tools

Accelyrs Discoverant

MS Excel

Job description

• Statistical & data analytics applications (outside of Excel)
• Date experience with batch records
• Bio Tech/Pharma industry preferred

Job Description:

The candidate will be responsible for supporting product robustness for the commercial biologics portfolio in client and third party manufacturing sites. Duties include supporting the Continued Process Verification program through leading meetings, supporting statistical process control documentation and maintaining data analytics systems. The role will include data entry and management of data.

Duties/Responsibilities:

• Provide support to maintain the product/site Statistical Process Control (SPC) program, manufacturing performance trending and reporting
• Manage and support investigations as a result of robustness events and SPC trending
• Provide system administration/maintenance of the Discoverant system
• Manipulate existing data files, edit information that has previously been compiled, proofread new entries within the database for accuracy
• Create forms/pages for data entry as required and data mine completed Manufacturing Batch Records
• Compile, sort and verify accuracy of data to be entered and compare data entered against source documents

Qualifications:

• Knowledge of SOPs, cGMPs and the know how to work and manage within a regulatory environment
• Excellent verbal & written communications skills. Interpersonal/facilitation skills necessary to interface with and influence all levels of the organization.
• Demonstrated ability to take initiative, prioritize objectives from multiple projects, and to adhere to scheduled timelines while maintaining flexibility
• Proven leadership skills with ability to direct and influence a team
• Knowledge of MS Word and Excel a must
• Strong technical background with knowledge of data management and ability to work with different data sources across different platforms
• Perform hands-on analysis of large volumes of data
• Easily pick up new technology
• Exceptional attention to detail
• Effective time management and project management
• Able to learn quickly working with new databases and create forms for data entry
• Experience with data analytics software such as Accelyrs Discoverant is preferred
• Experience performing statistical analysis and experience using a statistical software program is preferred
• Able to coordinate review and approvals of documentation through quality systems
• Knowledge of manufacturing operations, especially biopharmaceutical manufacturing operations is preferred

Education/Experience:

Bachelors Degree in Chemistry, Chemical Engineering, Biomedical Science or equivalent degree required. At least one year experience supporting a Continued Process Verification Program preferred.