Quality Process Engineer

Job Description

Job Description

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 .

Requirements

Required Qualifications

Preferred Qualifications