TSMS Engineer

INCOG BioPharma Services; Fishers (IN); On-site; USD 85,000 - 120,000; Full time

Job summary

INCOG BioPharma Services in Fishers, IN is seeking a Technical Transfer Engineer to support tech transfer, process validation, GMP floor activities, and continued process verification for clinical and commercial programs.

You will autonomously scale up and transfer processes to full-scale manufacturing, select appropriate GMP equipment, author critical documents, monitor data, and drive root-cause investigations with cross-functional teams.

Qualifications

• GMP experience in pharmaceutical manufacturing required.
• Experience in technical transfer for pharma or related industry.
• Ability to work with cross-functional teams and communicate with customers.

Responsibilities

• Scale up and transfer processes to full-scale manufacturing based on data.
• Select appropriate GMP equipment and develop technical docs (Tech Transfer Plan, Gap Assessments, PFD, Summary Reports, FMEA).
• Represent TSMS in project teams and communicate with customers as SME for manufacturing processes.
• Author GMP documentation (Master Batch Records, BOM, Processing Forms).
• Monitor process data, identify trends and propose actions.

Skills

GMP experience

Technical transfer

Cross-functional collaboration

Education

Bachelor's degree in Science or Engineering

Master's degree in Science or Engineering preferred

Job description

The Technical Services and Manufacturing Sciences (TSMS) Technical Transfer Engineer will be responsible for supporting all facets of Tech transfer, Process Validation, GMP Floor Support, and Continued Process Verification in accordance with current good manufacturing (cGMP) for clinical and commercial programs. This role will provide strong technical oversight to the production to ensure robust and reliable production processes are established.

Essential Job Functions:

• The Technical Transfer Engineer is responsible for autonomously scaling up and transferring process into full scale manufacturing process based on data generated internally or received from the client
• Select appropriate equipment and single-use components for GMP manufacturing and develop technical documentation such as Tech Transfer Plan, Gap Assessment, Process Flow Diagram, Summary Reports and Process FMEA
• Represents TSMS in project teams and communicates directly with customers. Recognized as Subject Matter Expert for the manufacturing processes
• Author GMP manufacturing documentation including Master Batch Records, Bill of Materials and Processing Forms
• Monitor Process Data, identify trends and propose actions as necessary
• Leads technical troubleshooting and investigations of process issues to support root cause analysis, product impact assessment and effective corrective and preventive actions
• Provide technical guidance and oversight to Operations and Validation group to support Process Performance Qualification and Continuous Process Verification
• Collaborate with cross-functional team to assess and implement new technology for GMP manufacturing
• Able to assess impact of changes to the product, process, equipment, procedures and/or materials
• Manage timelines and appropriately prioritize critical path tasks to meet deadlines
• Other responsibilities as required

Special Job Requirements:

• Bachelors' degree in Science or Engineering
• Masters' degree in Science or Engineering preferred
• 1-3 years of GMP experience required
• Experience in Technical Transfer for pharmaceutical or related industry

Additional info about INCOG BioPharma Services:

At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.

If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.

INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.

Qualified applicants must be authorized to work in the United States on a full-time basis. INCOG will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

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