Technical Transfer Engineer

Lead Candidate; Fishers (IN); On-site; Full time

Benefits offered by this job

Paid time off based on tenure

11 paid holidays

401(k) plan with company match

Choice of health & wellness plans

Onsite wellness facility

Employee engagement activities

Job summary

A dynamic contract development and manufacturing organization is seeking a Technical Transfer Engineer in Fishers, Indiana. The position involves supporting Tech transfer, Process Validation, and GMP Floor Support. Qualifications include a Bachelor's degree in Science or Engineering, 1-3 years of GMP experience, and experience in the pharmaceutical industry. The company offers a vibrant culture with excellent benefits, promoting a supportive and engaging work environment.

Qualifications

• 1-3 years of GMP experience required.
• Experience in Technical Transfer for pharmaceutical or related industry.

Responsibilities

• Support Tech transfer, Process Validation, and GMP Floor Support.
• Scale up and transfer process into full scale manufacturing.
• Develop Technical documentation for GMP manufacturing.
• Monitor Process Data and identify trends.
• Lead technical troubleshooting and investigations.

Skills

GMP experience

Technical Transfer

Process Validation

Technical documentation

Education

Bachelor's degree in Science or Engineering

Master's degree in Science or Engineering

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.

There is a growing need globally for more CDMOs (contract development and manufacturing organization) in the pharmaceutical industry to provide comprehensive services from drug development through drug manufacturing.

At INCOG, they are more than just a CDMO. A better way to create more meaningful experiences. A better way to create a culture that everyone can thrive and succeed in. At their core, that is who they are—a dedicated team that believes they can always be better.

Join the team at INCOG, a world-class CDMO for parenteral injectable drugs, shaping a new future for patients, for yourself, and for INCOG’s clients.

WHAT?

• 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

YOU!

• 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

Why INCOG?

• Paid time off, based on tenure
• 11 paid holidays
• 401(k) plan with company match up, vested immediately
• Choice of health & wellness plans
• FSA and HSA options
• Onsite wellness facility
• Employee engagement activities; food trucks, monthly luncheons, fundraising events, team building competitions, offsite celebrations

Don’t meet all the requirements? Don’t sweat! We’re always looking for an excuse to discuss your next opportunity. You might just surprise yourself…

Lead Candidate wholeheartedly supports Equality and Diversity in employment and opposes all forms of unlawful or unfair discrimination on the grounds of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.