Senior Process Validation Engineer

incog; Fishers (IN); On-site; USD 110,000 - 140,000; Full time

Job summary

INCOG BioPharma Services in Fishers, IN is seeking a Senior Process Validation Engineer to lead Process Validation, GMP Floor Support and Continued Process Verification for clinical and commercial programs. You will independently perform Process Performance Qualifications, mentor junior staff, collaborate with cross-functional teams, manage client communications and support regulatory submissions.

Bachelor’s degree in Science or Engineering; 3–5 years GMP experience; strong CMC knowledge and

Qualifications

• Bachelor’s degree in Science or Engineering is required.
• Master’s degree in Science or Engineering is preferred.
• 3–5 years of GMP experience is required.
• 2+ years of process validation experience for formulation, aseptic filling and/or combination product 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.

Responsibilities

• 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.
• Demonstrate strong understanding of CMC regulatory requirements specifically with respect to process validation and support regulatory submissions.
• Effectively engage and collaborate with both internal and external team members across cross-functional groups and lead client interactions.
• Lead identification of continuous improvement opportunities and drive implementation of those improvements with measurable impact.
• Stay current with trends and practices in the industry to support best in class processes and share knowledge with team members.
• Other responsibilities as required.

Skills

GMP experience

Process validation

Leadership

Cross-functional teamwork

Communication

Analytical/problem-solving

Education

Bachelor's degree in Science or Engineering

Master's degree preferred

Tools

Microsoft Office

Statistical analysis software

Data analysis tools

Job description

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
• Demonstrate strong understanding of CMC regulatory requirements specifically with respect to process validation and support regulatory submissions
• Effectively engage and collaborate with both internal and external team members across cross-functional groups and lead client interactions
• Lead identification of continuous improvement opportunities and drive implementation of those improvements with measurable impact
• Stay current with trends and practices in the industry to support best in class processes and share knowledge with team members
• Other responsibilities as required

Special Job Requirements:

• 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