Director Packaging Engineering Jobs in Indiana (NOW HIRING)

Job Description

INCOG BioPharma Services is seeking an experienced and highly motivated Packaging Supervisor to lead second shift operations within the packaging department. This role is responsible for overseeing bulk and automated packaging activities for sterile drug products, ensuring safe, compliant, and efficient execution of all packaging operations.

The Packaging Supervisor provides direct leadership to Packaging Associates and Team Leads, driving performance to meet production goals while maintaining the highest standards of quality and cGMP compliance. This individual serves as a key operational leader, ensuring alignment with internal teams, client expectations, and regulatory requirements.

Essential Job Functions:

• Supervise and coordinate second shift packaging operations, including bulk and automated packaging of sterile injectable products.
• Lead, coach, and develop Packaging Associates and Team Leads to achieve production, quality, and safety objectives.
• Ensure all packaging activities are executed in compliance with cGMP regulations, SOPs, and company quality systems.
• Monitor production performance, identify issues, and implement corrective actions to meet or exceed production targets.
• Review and approve batch records, logbooks, and associated documentation for accuracy and completeness.
• Oversee line setup, changeovers, and equipment readiness to minimize downtime and maximize efficiency.
• Partner with Quality, Manufacturing, Maintenance, and Supply Chain teams to resolve operational issues and support continuous improvement initiatives.
• Escalate and support investigations related to deviations, non-conformances, and equipment failures.
• Ensure proper in-process inspections and controls are performed to maintain product quality and compliance.
• Drive continuous improvement efforts related to processes, documentation, and equipment performance.
• Maintain a safe work environment by enforcing safety procedures and promoting a culture of accountability.
• Support training initiatives, ensuring all personnel are qualified and compliant with training requirements.
• Manage shift handoff communications to ensure continuity between operations teams.
• Ensure cleanliness and sanitization of packaging areas in accordance with established procedures.

Special Job Requirements:

• Bachelor's degree in a scientific, engineering, or related field preferred; equivalent experience considered.
• Minimum of 5+ years of GMP pharmaceutical experience in packaging, manufacturing, or related operations.
• Minimum of 2+ years of leadership or supervisory experience in a regulated environment.
• Experience with sterile drug product packaging and/or injectable devices strongly preferred.
• Ability to work overnight/second shift hours and provide leadership support during off-hours operations.

Additional Preferences:

• Strong knowledge of cGMP regulations and pharmaceutical packaging processes.
• Proven leadership, coaching, and team development skills.
• Strong problem-solving and decision-making abilities in a fast-paced environment.
• Excellent documentation review and technical writing skills.
• Effective communication and cross-functional collaboration skills.
• High attention to detail with a focus on quality and compliance.
• Ability to manage multiple priorities and drive results with minimal oversight.
• Experience with automated packaging systems and equipment troubleshooting.
• Continuous improvement mindset with experience in Lean or operational excellence initiatives preferred.

INCOG's Benefits:

• Paid vacation days, amount based on tenure, and paid sick time
• 11 observed holidays
• 401(k) plan with company match up to 3.5% of salary, vested immediately
• Choice of health & wellness plans
• FSA and HSA programs
• Dental & vision care

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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