Process Engineer

Process Engineer

Sanford, Maine, United States

Position Summary

The Process Engineer serves as a key link between the Innovation, Engineering, Quality, and Operations teams. This role is responsible for driving process optimization, technical transfer, and validation activities to ensure consistent product quality and operational efficiency. The position requires strong attention to detail, effective cross-functional collaboration, and a commitment to continuous improvement within a fast-paced production environment.

Key Responsibilities

• Provide daily technical and quality support to production, participating in daily meetings and resolving plant-level issues.
• Ensure quality systems and documentation align with current and upcoming manufacturing requirements.
• Conduct technical reviews of process, formulation, and packaging changes to safeguard product integrity.
• Act as a key contributor to the Management of Change (MOC) process.
• Collaborate with cross-functional teams including Operations, Technology, Procurement, and external vendors to achieve quality and production targets.
• Support process validation, cleaning and sanitization (C&S) validation, and development of validation master plans.
• Lead product inspections, production line trials, and key performance indicator (KPI) monitoring.
• Prepare and execute validation protocols (IQ/OQ/PQ) in coordination with engineering.
• Conduct GMP and quality training sessions for site personnel.
• Apply quality and continuous improvement tools, including CAPA, change control, deviation investigations, and statistical process control (SPC)
• Lead site-level technology transfer and ensure compliance with all validation and documentation standards.

Qualifications

Required:

• Bachelors degree in Chemical Engineering, Mechanical Engineering, Chemistry, or a related technical field.
• 2-3 years of experience in a manufacturing or quality focused engineering role.
• Demonstrated project management, communication, and problem-solving skills in a fast-paced environment.

Preferred:

• Experience with quality systems, validation protocols, and cGMP standards (21 CFR 210 & 211).
• Familiarity with SAP, validation software (e.g., KNEAT), and InBatch or other process control systems.
• Background in a regulated or consumer product manufacturing environment.

Additional Details

• Benefits: Comprehensive benefits package available
• Relocation Assistance: Not provided
• Travel: Occasional