Senior Process Validation Engineer at INCOG BioPharma Services — Fishers, USA | Base Career

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TSMS – Senior Process Validation Engineer

The Senior Process Validation Engineer - Technical Services and Manufacturing Sciences (TSMS) will be responsible for leading 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 advanced technical leadership to ensure robust and reliable production processes are established and maintained across multiple programs.

This position will lead the delivery of technical guidance and assistance throughout the process validation of production processes.

The primary objective is to independently execute Process Performance Qualifications and Continued Process Validation activities while mentoring junior staff.

Essential Job Functions

Lead TSMS Process Validation activities by providing advanced technical guidance to operations and technical transfer project teams on Process Performance Qualification with minimal supervision
Independently create complex process qualification documentation such as Process Validation Master Plans, Protocols, Summary Reports, and related validation documents for multiple product lines
Serve as technical lead in project teams and manage customer communications. Recognized as Subject Matter Expert for multiple manufacturing processes
Author and review complex GMP manufacturing documentation including Master Batch Records, Bill of Materials and Processing Forms across multiple programs
Monitor and analyze Process Data across multiple manufacturing areas, identify trends and implement corrective actions independently
Lead technical troubleshooting and investigations of complex process issues to support comprehensive root cause analysis, product impact assessment and effective corrective and preventive actions
Lead cross-functional teams in assessing and implementing new technology for GMP manufacturing with strategic impact
Provide advanced technical guidance to team members in technical matters of process validation and mentor Entry Level engineers
Conduct comprehensive impact assessments of changes to the product, process, equipment, procedures and/or materials across multiple programs

Bachelor's degree in Science or Engineering required
Master's degree in Science or Engineering preferred
3-5 years of GMP experience required
2+ years of experience in process validation principles for formulation, aseptic filling and/or combination product (device assembly) processes
Strong understanding of CMC regulatory requirements and process validation methodologies
Advanced analytical and problem-solving skills with demonstrated leadership capabilities
Excellent communication skills and proven ability to lead cross-functional teams and manage client relationships

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.

By submitting your resume and details, you are declaring that the information is correct and accurate.

Advanced proficiency in Microsoft Office applications, statistical analysis software, and data analysis tools
Demonstrated ability to work independently in a fast-paced, regulated manufacturing environment
Experience with regulatory submissions (preferred) and client-facing technical presentations

Senior Process Validation Engineer

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TSMS – Senior Process Validation Engineer

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