Job Summary

The Process Engineering Manager will play a pivotal role in driving Federal Package’s product development initiatives. This individual will closely collaborate with R&D formulation to create new filled products that promote efficient production, leveraging existing equipment or exploring and integrating innovative technologies. The Process Engineering Manager will spearhead the initiation, validation, and implementation of processes from lab bench through commercial compounding and filling, ensuring the successful validation of new filled products and necessary modifications to optimize process efficiency while adhering to regulatory regulations. They are accountable for ensuring that all scaling to full-size production is executed properly.

Key Responsibilities

• Develop and execute Design of Experiments (DOE) to establish Critical Processing Parameters (CPP) during OTC validation batches, including parameter identification, data analysis, and process optimization to ensure consistent product quality and robust performance.
• Provide specialized expertise in developing and implementing foundational elements of process control, including the establishment of control charts, process parameters, and production standards that align with industry’s best practices and regulatory requirements.
• Manage multiple projects focused on new product introduction, process optimization, and cost savings.
• Lead and mentor a team of Process Engineers, promoting a culture of innovation and technical excellence.
• Own the process from lab bench to commercial production—initiate, validate, and implement manufacturing processes.
• Apply Lean/Six Sigma, DOE, and statistical tools to drive continuous improvement and troubleshoot complex technical challenges.
• Ensure full compliance with FDA/OTC regulations, including MoCRA and process validation standards.

Minimum Qualifications

• Bachelor’s in Engineering (Chemical, Mechanical, or related).
• 5+ years of experience scaling processes from lab to full-scale in an FDA-regulated manufacturing environment.
• Deep knowledge of OTC process validation, compounding/filling operations, and MoCRA requirements.
• Strong leadership, project management, and communication skills.
• Proven project management expertise, effectively coordinating multiple initiatives to meet timelines and quality assurance standards.
• Expertise in thermodynamics, mixing energy, and hands-on process troubleshooting.

Company Benefits

• Medical, Dental & Vision Insurance
• Flexible Spending Account
• Dependent Care Account
• Paid Time Off (PTO)
• Company Paid Short-Term Disability, Long Term Disability, & Life/AD&D
• 401k contributions
• Summer Flex Time
• Volunteer Time Off
• Bereavement Time Off
• New Parent Paid Leave
• And more!