Job Description

INCOG BioPharma is seeking an individual with subject matter expert (SME) capabilities in the inspection and/or packaging of sterile drug products. The primary purpose of this role is to provide strong compliance and Visual Inspection start-up process support as well as technical leadership in the creation and deployment of the visual inspection program within INCOG BioPharma Operations.

The primary function of this role is to facilitate the implementation and use of visual inspection processes and systems. This role will be responsible for developing and leading the inspection team and ensuring industry standards and regulatory requirements are met. This role will also provide direction related to automated visual inspection and packaging related technologies.

This is a 3rd shift role.

Essential Job Functions:

• Provide technical support and project leadership in the implementation of visual inspection program.
• Train inspection operations and develop their capabilities to ensure Visual Inspection program sustainability.
• Coordinate the development of visual inspection specifications that maintain product quality and compliance.
• Develop processes to maintain and control the visual inspection requirements and coordinate the development of process procedures.
• Serve as subject Matter Expert in visual inspection and packaging technologies and quality/compliance requirements.
• Assure compliance with cGMP requirements (current good manufacturing practices)
• Lead the team of qualified inspectors and manage manufacturing activities.

Special Job Requirements:

• BS or MS in Engineering or Science or 8 years related experience in the development or support of pharmaceutical inspection processes, quality systems or a closely related field.
• Must pass health and visual checks and eye inspections annually.
• Previous leadership experience required.

Additional Preferences:

• Knowledge of statistics, process control, quality engineering, sampling requirements, statistical techniques, and process capability.
• Familiarity with relevant quality and regulatory requirements and trends and cGMP's.
• Strong communication skills and the ability to build relationships with colleagues across all levels of the organization, including business managers, operations leaders, and technical leaders.
• Strong understanding of Visual Inspection and Packaging requirements.
• Knowledge of Aseptic techniques and processing.

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.