Engineer - TS/MS Process Data in Somerville

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Job DescriptionJob Description

Position Summary:

This position will be responsible for data analysis support of manufacturing processes. This position will interact with the Manufacturing, Quality Assurance and Quality Control departments. Some interaction with other Celltrion Branchburg sites or contract manufacturers may be required. Knowledge of cell culture, purification and support systems is a plus. Spreadsheet experience required, database experience a plus.

Key Objectives/Deliverables:

Manage for Results /Strategic Planning:

1. Verifies the accuracy of the data entered into the in-process database and ensures that all of the data entries are complete.
2. Creates and maintains data entry forms for use by manufacturing staff, providing training as necessary on data entry procedures. Anticipates customer needs and handles nonstandard requests.
3. Ensures the data structure remains consistent with process changes that may occur; reviews batch records as necessary to ensure that data is recorded consistently for different products. Requires technical knowledge within discipline.
4. Assists with the monitoring (trending) and analysis of manufacturing production data to support: process monitoring, process deviations, process validation, technology transfer documentation, BLA filings, annual manufacturing summaries for regulatory documentation, etc.
5. Assists with the maintenance and troubleshooting of the manufacturing in-process database while providing sound problem-solving skills to complex issues, as applicable.
6. Provides in-process data for technical reports supporting technology transfers, deviation/adverse event reporting and process analysis/trending. May be asked to author or provide content for some technical reports. Educates self and others on complex issues and gains support for ideas.
7. Contributes to in cross-site data sharing initiatives.
8. When requested, provides in-process data for technical reports supporting technology transfers, deviation/adverse event reporting and process analysis/trending.
9. May participate / lead projects or programs with various levels of risks. Makes decisions that impact own priorities and allocation of time to meet deadlines.
10. Provides sound problem solving skills to complex issues.
11. Writes SOPs as they relate to the activities of the TS/MS group. May assist with SOPs from other manufacturing groups.
12. Understands and performs all job responsibilities in compliance with safety and regulatory expectations, as well as cGMP.

Basic Requirements:

1. B.S. in a scientific discipline or equivalent skills and relevant experience
2. Strong mathematical and analytical skills.
3. Word, Excel, and PowerPoint experience required.
4. An understanding of current Good Manufacturing Practices required.
5. Excellent oral and written communication skills.
6. Proficiency with software such as Microsoft Office Suite and JMP.

Additional Preferences:

1. SQL database experience a plus.
2. JMP and coding experience a plus.
3. Experience in cell culture and/or protein purification manufacturing a plus.
4. Familiarity with TrackWise and LIMS a plus.

This is an exempt, salaried role with an anticipated compensation range of $72,000 - $96,000

Celltrion Branchburg, LLC offers a comprehensive benefits package that includes paid time off (holidays, vacation, and additional leave), medical, dental, and vision insurance, life insurance, a company-matched retirement savings plan, wellness programs, and short- and long-term coverage.

The position does not require travel; it may require on-call availability and could involve shift work. Hybrid work flexibility is available based on business needs; relocation assistance is not provided.

Celltrion is an EEO/Affirmative Action Employer and does not discriminate on the basis of , , , , , , , expression, , protected veteran status, or any other legally protected status.

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