Process Engineer

Process Engineer

Location: Sanford, Maine

Industry: Consumer Products / Cosmetics
Category: Manufacturing – Quality

Position Summary

The Process Engineer serves as a key connection point between cross-functional teams—Innovation, Engineering, Technical Management, Plant Operations, and Quality. This role operates at a fast pace with high attention to detail and plays an active part in driving quality performance and customer satisfaction.

Core technical responsibilities include process optimization and validation, technical transfer activities, system configuration and data setup, cleaning and sanitization validation leadership, and management of production recipes and change control processes.

Key Responsibilities

• Provide hands-on support to production areas, addressing day-to-day quality concerns and continuous improvement initiatives.
• Participate actively in daily operational and quality meetings to align on plant priorities.
• Ensure quality systems and documentation are up to date and reflect current and future production needs.
• Review and assess changes in product specifications, formulations, processes, and packaging to ensure compliance with quality standards.
• Act as a key contributor in the Management of Change (MOC) process.
• Collaborate with internal stakeholders—including Operations, Technology, Business Units, Procurement—and with external partners and suppliers to support production and quality goals.
• Oversee validation activities, including cleaning and sanitization (C&S), process qualification (PQ), and associated risk assessments. Maintain and update the site’s validation master plan and develop protocols in coordination with engineering teams.
• Support new product launches through process reviews, validation, and stability testing coordination.
• Participate in external audits and site inspections as needed.
• Lead product inspections, line trials, and track key quality performance metrics.
• Conduct training sessions on topics such as Good Manufacturing Practices (GMP), validation principles, and quality standards.
• Utilize quality and process tools—including Change Control, CAPA, Failure Investigation, Control Charts, and Deviation Management—to drive improvements.
• Support the implementation of technology transfer standards and ensure site adherence to these protocols.

Qualifications

• Required:
• Bachelor’s degree in Chemical or Mechanical Engineering, Chemistry, or a related technical discipline.
• 2–3 years of experience in manufacturing, quality engineering, or a related field.
• Proven ability to manage multiple projects, communicate effectively, and deliver results in a fast-paced production environment.
• Preferred:
• Strong working knowledge of quality systems, validation, cGMP standards, and regulatory requirements such as 21 CFR 210/211.
• Experience in a regulated manufacturing environment (e.g., FDA-regulated consumer or cosmetic products).
• Familiarity with enterprise or validation systems such as SAP, KNEAT, or InBatch, or equivalent manufacturing and quality management software.