Job Overview: The Production Engineer focuses on maximizing equipment reliability, improving production efficiency, reducing downtime and waste, and ensuring compliance with Current Good Manufacturing Practices (cGMPs), 21 CFR Part 111, 21 CFR Part 117, and ANSI 455-2 and applicable quality standards. Responsibilities include the setup, troubleshooting, and continuous improvement of our processes. This is a hands-on position that directly impacts production performance, product quality, regulatory compliance, and operational excellence. This individual must adhere to cGMP (Current Good Manufacturing Practices), Standard Operating Procedures, and Food Safety Regulations.
Key Responsibilities
Process Optimization & Continuous Improvement
- Utilize continuous improvement frameworks to maximize line efficiency, reduce setup times, and minimize material scrap/waste
- Conduct root-cause analyses on machine malfunctions and implement corrective and preventive actions (CAPA)
- Partner with the Maintenance team to diagnose chronic equipment issues and develop equipment reliability strategies
Machine Setup & Changeover
- Lead and support the setup, calibration, and changeover of encapsulation machines, rotary tablet presses, and stick pack equipment to match batch record specifications
- Coordinate tooling changes, adjustments, and preventative maintenance to ensure optimal equipment performance
Packaging Line Support
- Oversee the end-to-end packaging process for dietary supplements, including bottle-filling, blistering, sachet, and stick-pack lines
- Ensure proper operation, troubleshooting, and material loading of packaging machinery to maintain throughput and reduce waste
- Monitor package seals, fill weights, and label accuracy to meet strict quality guidelines
Process Optimization & Continuous Improvement
- Utilize continuous improvement frameworks to maximize line efficiency, reduce setup times, and minimize material scrap/waste
- Conduct root-cause analyses on machine malfunctions and implement corrective and preventive actions (CAPA)
- Partner with the Maintenance team to diagnose chronic equipment issues and develop equipment reliability strategies
Quality & Regulatory Compliance
- Enforce strict adherence to Current Good Manufacturing Practices (cGMP) and 21 CFR Part 111 regulations for dietary supplements
- Review and approve executed Batch Production Records (BPRs) and document all validated process parameters
Qualifications/Requirements
Technical Knowledge
- Strong mechanical aptitude with direct, hands-on experience setting up and troubleshooting encapsulation, tablet compression, and stick pack machines
Regulatory Skills
- Deep understanding of cGMP guidelines, standard operating procedures (SOPs), and equipment validation processes
Soft Skills
- Strong problem-solving abilities, excellent cross-functional communication, and the capacity to adapt to a fast-paced, dynamic production schedule
Education/Experience
- Bachelor’s degree in Industrial Engineering, Manufacturing Engineering, Packaging Engineering, or a related field
- 3-5 years of hands-on experience supporting manufacturing operations in dietary supplement, pharmaceutical, or food/beverage industries
Preferred Skills
- Experience implementing Lean Manufacturing or Six Sigma methodologies
- Preferred HACCP, PCQI Certification
- Familiarity with ERP/MRP enterprise software systems
Benefits:
- 401(k)
- 401(k) matching
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Parental leave
- Retirement plan
- Vision insurance
Work Location: In person
