Engineer, Manufacturing Science and Technology (MS&T)

Catalent - Bloomington, IN

Full-time - Entry Level

Bloomington, IN

10,001+ employees

Chemical Manufacturing

About the position

The Engineer, Manufacturing Science and Technology (MS&T) at Catalent plays a crucial role in the pharmaceutical industry by scaling up and transferring processes into full-scale manufacturing. This position is essential for ensuring that the processes developed in the lab or pilot stages are effectively transitioned to large-scale production. The Engineer will work closely with the Process Development team or clients to understand the data generated during the initial stages and will be responsible for developing the necessary technical documentation, such as Process Flow Diagrams and Process Descriptions, to guide the operation of these processes at scale. In this role, the Engineer will select appropriate equipment and single-use components to perform the manufacturing processes. They will also be tasked with writing or directing the writing of Good Manufacturing Practice (GMP) documentation, including Process Batch Records and Sample Plans. Providing technical training to operators is another key responsibility, ensuring that all team members are well-equipped to handle the processes effectively. Monitoring process data is a critical aspect of this position, where the Engineer will identify trends, present data, and propose necessary actions to address any issues that arise. They will also conduct technical troubleshooting and investigations into process issues, ensuring that any challenges are swiftly resolved. Additionally, the Engineer will provide guidance to the validation group to support Process Validation and Continued Process Verification, working collaboratively with Process Development and Process Engineering teams to assess and implement new technologies in large-scale manufacturing. The role requires maintaining relationships with process technology vendors to stay updated on new technology developments, and the Engineer may also be assigned other duties as needed. This position operates within a dynamic, fast-paced environment, emphasizing a commitment to quality and compliance, as well as the safety of patients and employees.

Responsibilities

• Select appropriate equipment and single-use components for manufacturing processes.
• Develop technical documentation such as Process Flow Diagrams and Process Descriptions.
• Meet with Process Development or client technical teams to understand data and develop in-process test strategies.
• Write or direct the writing of GMP manufacturing documentation, including Process Batch Records and Sample Plans.
• Provide technical training to operators as necessary.
• Monitor process data, identify trends, and propose actions based on findings.
• Perform technical troubleshooting and investigations of process issues.
• Write or direct the writing of post run reports, such as Manufacturing Campaign Reports.
• Provide technical guidance and oversight to the validation group for Process Validation and Continued Process Verification.
• Work with Process Development and Process Engineering to assess and implement new technology in large scale manufacturing.
• Maintain relationships with process technology vendors to understand new technology development.
• Perform other duties as assigned.

Requirements

• Bachelor's degree in Science or Engineering and 1+ years of biopharmaceutical industry experience, required.
• Master's degree in Science and Engineering, preferred.
• 1 year GMP or regulated industry experience, required.
• Ability to read and understand English-written job instructions and safety requirements.

Nice-to-haves

• Experience with Continuous Improvement Processes.
• Familiarity with biopharmaceutical manufacturing processes.

Benefits

• Competitive medical benefits and 401K
• 152 hours of PTO + 8 Paid Holidays
• Dynamic, fast-paced work environment
• Opportunity to work on Continuous Improvement Processes
• Career advancement opportunities.