Principal MSAT Engineer (AVI & Device)

Description

The Principal MSAT Engineer for Automated Vision Inspection & Device is an exciting role in a fast-growing team with lot of growth opportunities. This role is responsible for overseeing and enhancing the visual inspection program to ensure the highest quality standards for Biopharmaceuticals products. This role involves providing expert guidance on inspection methodologies, leading training programs, optimizing systems, and ensuring compliance with regulatory requirements. The person in this role will also leverage in-depth technical knowledge and strong analytical skills to drive product quality and patient safety.

Essential Job Functions:

• Lead the design, development, and implementation of risk-based strategies for visual inspection of different products (e.g., syringes, cartridges, vials)

• Serve as go-to expert on visual inspection processes, equipment and quality standards.

• Conduct root cause analysis and implement corrective and preventive actions (CAPA) for quality-related events.

• collaborate with cross-functional teams involving process engineering, operations, quality assurance to identify and implement process improvements.

• Ensure compliance with FDA and global regulatory bodies by keeping inspection processes and documentation up to date.

• Act as a subject matter expert for the development and maintenance of internal strategy documents and execution documents to support visual inspection programs.

• Participate in internal and external audits, providing expert insights and support.

• Explore and evaluate new technologies and methodologies in visual inspection.

Special Job Requirements:

• Bachelor’s degree in Chemistry, Engineering, or a related field; Advanced degree preferred.

• 10+ years of experience working in a GMP-regulated environment

• 5+ years of experience in visual inspection for biopharmaceutical products

• In-depth knowledge of visual inspection standards, practices, and equipment

• Familiarity with regulatory guidance (FDA, EMA) and experience in regulatory inspections.

Additional Preferences:

• Proven record of developing training programs and mentoring inspection team

• Experience with automated visual inspection systems

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.

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