Validation Engineer

Prolim; Pontiac (IL); On-site; USD 60,000 - 90,000; Full time

Job summary

An established industry player is seeking a skilled Validation Engineer to lead manufacturing process validation efforts. In this role, you will conceive, plan, and execute validation studies while ensuring compliance with all regulatory requirements. You will create robust validation documents and protocols, manage routing in PLM tools, and apply a risk-based approach to validation. This position offers a unique opportunity to contribute to quality and compliance in a dynamic environment, where your expertise will drive successful project outcomes and ensure adherence to industry standards. Join a team that values attention to detail and excellent communication skills, and make a significant impact in the field of manufacturing validation.

Qualifications

• 3+ years of experience in manufacturing engineering validation activities.
• Experience in medical device or regulated industry preferred.

Responsibilities

• Leads manufacturing process validation plans and studies.
• Ensures compliance with regulations and quality operations.

Skills

Manufacturing Process Validation

Risk-Based Approach Guidelines

Regulatory Compliance

Project Management

Technical Documentation

Education

Degree in Science or Engineering

Tools

PLM Tools

Microsoft Office

Job description

Job Description

Conceives, plans, and executes manufacturing process validation plans and studies.

1. Adheres to Change Control and Design Control requirements.
2. Creates robust validation documents such as Master Validation Plans/Reports, IQ, OQ, & PQs.
3. Leads the writing and execution of IQ/OQ/PQ protocols.
4. Manages RCH/PCH - Routing in MAP Agile & follow-up till release.
5. Updates Control Plan (CP), Assembly Procedure (AP), and Traveler document (TD).
6. Prepares protocols & executes Test Method Validation (TMV).
7. Applies risk-based approach guidelines, international regulatory requirements, and standards in validation experience.

Quality and Compliance Responsibilities

Ensures all activities comply with regulations and laws governing business and quality operations. Responsible for ensuring compliance with all local, national, international, and company regulations, policies, and procedures for health, safety, and environmental compliance.

Education

Degree qualified – ideally in science or engineering. Other further education and work experience may be considered.

Experience

Minimum 3 years’ experience in manufacturing engineering validation activities. Some experience in the medical device or related regulated industry. Project management and leadership experience. Extensive experience in preparing technical documents. Proficient in PLM tools & Microsoft Office.

Personal Attributes

Excellent written and oral communication skills. Attention to detail.