Validation Engineer

TechDigital Group; Los Angeles (CA); On-site; USD 70,000 - 110,000; Full time

Job summary

An established industry player is seeking a skilled Validation Engineer to lead manufacturing process validations in a dynamic environment. This role involves creating robust validation documents, executing protocols, and ensuring compliance with regulatory standards. The ideal candidate will possess a degree in science or engineering and have a minimum of three years of relevant experience, particularly in the medical device industry. Join a dedicated team where your attention to detail and project management skills will contribute to high-quality outcomes and regulatory success. This position offers a unique opportunity to impact product quality and safety in a collaborative setting.

Qualifications

• Minimum 3 years of experience in manufacturing engineering validation.
• Proficient in creating validation documents and protocols.

Responsibilities

• Lead the writing and execution of validation protocols.
• Ensure compliance with health, safety, and environmental regulations.

Skills

Manufacturing Process Validation

Project Management

Technical Documentation

Communication Skills

Attention to Detail

Teamwork

Education

Degree in Science or Engineering

Further Education and Work Experience

Tools

PLM Tools

Microsoft Office

Job description

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

1. Adhere to the Change Control and Design Control requirements.
2. Create robust validation documents such as Master Validation Plans / Report, IQ, OQ, & PQ's.
3. Lead the writing and execution of IQ/OQ/PQ protocols.
4. RCH/PCH - Routing in MAP Agile & follow up till release.
5. Update Control Plan (CP), Assembly Procedure (AP) & Traveler document (TD).
6. Prepare protocol & execute Test Method validation (TMV).
7. Validation experience using risk-based approach guidelines, international regulatory requirements, and standards.

Quality and Compliance Related Responsibilities

1. Ensure that all activities are carried out in compliance with all regulations and laws governing business and quality operations.
2. Responsible for ensuring compliance with all local, national, international and company regulations, policies and procedures for Health, Safety and Environmental compliance.

Education

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

Experience

• Minimum 3-years' experience of working on manufacturing engineering validation activities.
• Some previous experience in medical device or related regulated industry.
• Experience in project management and project leadership.
• Extensive experience in the preparation of technical documents.
• Proficient in PLM tools & Microsoft Office.

Personal Attributes

• Excellent written and oral communication skills.
• Attention to detail.
• Ability to work as a team.
• Manage your own time and workload.
• Excellent organizational skills.