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TSMS - Process Validation Engineer

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

This position will support the delivery of technical guidance and assistance throughout the process validation of production processes. The primary objective is to assist with Process Performance Qualifications and Continued Process Validation activities under the supervision of senior technical staff.

Essential Job Functions:

- Support TSMS Process Validation activities by providing technical assistance to operations and technical transfer project teams on Process Performance Qualification under supervision

- Assist with the creation of process qualification documentation such as Process Validation Master Plans, Protocols, Summary Reports, and related validation documents

- Participate in project teams and support customer communications under guidance of senior staff. Developing expertise as Subject Matter Expert for manufacturing processes

- Assist with authoring GMP manufacturing documentation including Master Batch Records, Bill of Materials and Processing Forms

- Support monitoring of Process Data, assist with trend identification and propose actions under supervision

- Assist with technical troubleshooting and investigations of process issues to support root cause analysis, product impact assessment and effective corrective and preventive actions

- Support cross-functional teams in assessing and implementing new technology for GMP manufacturing

- Provide technical support to other team members in technical matters of process validation under guidance

- Assist with assessing impact of changes to the product, process, equipment, procedures and/or materials

- Develop understanding of CMC regulatory requirements specifically with respect to process validation

- Learn to engage and effectively collaborate with both internal and external team members across cross-functional groups

- Support identification of continuous improvement opportunities and assist with implementation of those improvements

- Stay current with trends and practices in the industry to support best in class processes

- Other responsibilities as required

Special Job Requirements:

- Bachelor's degree in Science or Engineering required

- Master's degree in Science or Engineering preferred

- 0-2 years of GMP experience preferred

- Basic understanding of process validation principles for formulation, aseptic filling and/or combination product (device assembly) processes

- Interest in learning CMC regulatory requirements and process validation methodologies

- Strong analytical and problem-solving skills

- Excellent communication skills and ability to work effectively in cross-functional teams

- Proficiency in Microsoft Office applications and basic data analysis tools

- Ability to work in a fast-paced, regulated manufacturing environment

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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