Integration (Process Validation) Engineer

Description:

Integration (Process Validation) Engineer

Medical Device Contract Manufacturer – Flexible Films & Packaging

Position Summary

The Integration (Process Validation) Engineer is responsible for leading and supporting process validation and manufacturing integration activities for medical device packaging, flexible film converting, and related manufacturing processes. This role ensures manufacturing processes are developed, validated, transferred, and maintained in compliance with FDA Quality System Regulation (21 CFR Part 820), ISO 13485, customer requirements, and internal quality standards.

The engineer will work cross-functionally with Operations, Quality, Design Engineering, and customers to support new product introductions, process improvements, equipment qualifications, and ongoing manufacturing validation activities.

Reporting Structure

• Reports To: VP of Quality and Integration Engineering

• Department: Integration Engineering

Essential Duties and Responsibilities

• Develop and execute IQ, OQ, and PQ validation protocols and reports.

• Lead validation activities for flexible film converting, RF welding, heat sealing, pouch manufacturing, printing, and labeling operations.

• Perform process capability studies and statistical analysis to support validation activities.

• Establish process windows, critical process parameters, and acceptance criteria.

• Support new product introductions (NPI) from concept through commercial production.

• Identify and implement process improvements focused on quality, efficiency, scrap reduction, and throughput.

• Lead root cause investigations and corrective actions related to process performance.

• Ensure compliance with FDA 21 CFR Part 820 / QMSR, ISO 13485, GMP requirements, and customer-specific quality requirements.

• Support internal, customer, and regulatory audits.

Project Management & Customer Communication

• Lead cross-functional project activities related to process validation, equipment implementation, and new product integration.

• Develop and manage project timelines, deliverables, and validation schedules to support customer and internal milestones.

• Coordinate activities between Engineering, Quality, Operations, Supply Chain, and customer teams to ensure successful project execution.

• Serve as a primary technical point of contact for customers during new product introductions, validation activities, process transfers, and ongoing manufacturing support.

• Communicate project status, technical risks, validation progress, and issue resolution plans to internal leadership and customers.

• Facilitate customer meetings, technical reviews, and validation planning discussions.

• Support quotation reviews and provide technical input related to manufacturability, process capability, and validation requirements.

• Collaborate with customers to understand product requirements, critical-to-quality characteristics, and regulatory expectations.

• Support customer visits, audits, factory acceptance activities, and production trials as needed.

Requirements:

Required Qualifications

• Bachelor’s degree in Engineering or related technical field required.

• 3+ years of engineering experience in a regulated manufacturing environment.

• Experience with process validation in regulated manufacturing.

• Working knowledge of IQ/OQ/PQ methodologies, statistical analysis, root cause analysis tools, and risk management methodologies.

• Knowledge of FDA 21 CFR Part 820 and ISO 13485 requirements.

• Strong technical writing and documentation skills.

Preferred Qualifications

• Experience in flexible films, medical packaging, or converting operations.

• Experience with RF welding, heat sealing, extrusion, laminating, pouch manufacturing, or printing technologies.

• Experience supporting customer audits and regulatory inspections.

• Experience with EQMS systems.

Key Competencies

• Strong analytical and problem-solving skills

• Project management and organizational skills

• Attention to detail and documentation accuracy

• Effective communication and collaboration skills

• Ability to manage multiple priorities in a fast-paced manufacturing environment

• Customer-focused mindset