Quality Process Engineer

Quality Process Engineer

Sanford, Maine 

80-115K + Bonus + Full Benefits 

Job Summary

The Quality Process Engineer acts as a critical link between Innovation/Technical Development teams and Plant Operations/Quality Assurance. This role is responsible for driving plant quality performance and continuous consumer satisfaction through meticulous process optimization, robust technical transfer, and comprehensive validation leadership in a regulated manufacturing environment. The successful candidate must thrive in an energetic, fast-paced setting while maintaining strict attention to detail and promoting effective internal and external networking.

Key Responsibilities

• Process Validation & Quality Compliance Leadership:
• Oversee and manage the site validation program, including Cleaning and Sanitization (C&S) validation plan leadership and execution.
• Conduct risk analysis, maintain and update the Validation Master Plan, and develop Performance Qualification (PQ) protocols, supporting IQ/OQ in partnership with the Engineering team.
• Ensure compliance with quality standards, including cGMP and 21 CFR 210 & 211.
• Technical Transfer & System Management:
• Lead the Technology Transfer Quality Standard application specific to site activities.
• Manage SAP item setup and ensure accountability for the Management of Change (MOC) process.
• Lead the creation, optimization, and management of Inbatch recipes.
• Conduct technical reviews of changes in specifications, processes, formulas, packaging, and labeling to ensure product quality.
• Ensure site quality systems are configured for current and upcoming production requirements in a timely manner.
• Operations Support & Continuous Improvement:
• Provide daily on-the-floor support to address quality issues and continuous improvement initiatives, actively participating in site Standard Daily Meetings (SDM) and Internal Quality Area Meetings.
• Utilize quality tools such as Change Control, Failure Investigation, Control Charts, Corrective & Preventive Actions (CAPA), and Notice of Deviations to drive continuous improvement.
• Lead product inspections, line trials, and other Quality Key Performance Indicator (KPI) activities.
• Cross-Functional Partnership & Training:
• Interface effectively with key business partners including Operations, Technology, Procurement, and Vendors.
• Conduct training sessions on topics like GMP, quality standards, and validation.

Required Qualifications

• Education: Bachelor's degree in Chemical / Mechanical Engineering, Chemistry, or a related science/engineering discipline.
• Experience: A minimum of 2-3 years of experience in manufacturing, a quality role, or equivalent. (Mid-Senior level experience preferred).
• Skills: Demonstrated project management skills and the ability to communicate effectively and deliver results in a fast-paced work environment.

Preferred Qualifications

• A strong background in quality systems, process validation, and a thorough understanding of cGMP and 21 CFR 210 & 211.
• Prior experience working in a regulated industry (e.g., FDA-regulated).
• Working knowledge of SAP, validation software (e.g., KNEAT), InBatch, or similar plant/quality-related computer systems.