Job Description

Job Description

Job Title: Quality Process Engineer

Location: 27 Community Dr, Sanford, ME 04073

Industry: Consumer Products / Cosmetics

Job Category: Manufacturing – Quality

Employment Type: Full-time (Onsite)

Overtime Eligible: No

Benefits: Full benefits package provided

Travel Requirement: Occasional

About the Role

The Quality Process Engineer serves as a critical link between the Innovation team—including Implementation & Support (I&S), Product Development & Innovation (PD&I), Category Technical Managers, Plant Operations, and Quality.** This position requires strong technical expertise, attention to detail, and the ability to work at an energetic pace.

The Quality Process Engineer is highly visible in promoting plant quality performance, process optimization, validation, and consumer satisfaction while ensuring strong internal and external networking.

Key Responsibilities

Quality & Continuous Improvement

• Provide daily support to plant operations by addressing quality issues, leading problem resolution, and driving continuous improvement initiatives.
• Actively participate in the production area, site Standard Daily Meeting (SDM), and Internal Quality Area Meetings.
• Conduct technical reviews of changes in specifications, processes, formulas, packaging, and labeling to ensure compliance with quality standards.
• Key contributor to the Management of Change (MOC) process.

Process Validation & Control

• Lead and manage the site validation program, including Cleaning & Sanitization (C&S) validation plans.
• Conduct risk analysis, maintain and update the validation master plan, and develop validation protocols (PQ).
• Support IQ/OQ in collaboration with the engineering team.
• Lead product inspections, line trials, and Quality Key Performance Indicator (KPI) monitoring.

Technical Transfer & Systems

• Ensure timely setup and configuration of site quality systems to support production requirements.
• Oversee SAP item setup, recipe creation (InBatch), optimization, and management.
• Drive technical transfer activities aligned with site-related quality standards.

Training, Compliance & Audits

• Conduct training sessions on GMP, validation, quality systems, and standards.
• Support pre- and post-launch review meetings, stability sample testing, and external audit participation.
• Utilize quality tools such as Change Control, Failure Investigations, Control Charts, CAPA, and Deviations to drive compliance and improvement.

Qualifications

Required:

• Bachelor’s degree in Chemical/Mechanical Engineering, Chemistry, or a related science/engineering discipline .
• 2–3 years of experience in manufacturing, quality, or equivalent technical roles.
• Demonstrated project management skills with the ability to communicate effectively and deliver results in a fast-paced environment.

Preferred:

• Strong background in quality systems, process validation, and regulatory compliance .
• Knowledge of cGMP and FDA regulations (21 CFR 210 & 211).
• Experience in regulated industries (e.g., FDA, pharma, cosmetics, consumer goods).
• Working knowledge of SAP, validation software (e.g., KNEAT), InBatch, or similar plant/quality-related systems .

Candidate Profile

• Experience Level: 2–5 years (Mid-Senior Level)
• Education: Bachelor’s degree required
• Management Experience: Not required

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