Validation Engineer

Hydrogen Group is seeking an experienced Validation Engineer for a 9-month contract opportunity in Irvine, CA.

This position will support a major manufacturing transfer initiative and will focus on the development, execution and documentation of equipment and fixture validations. The successful candidate will have strong hands-on validation experience, excellent technical writing skills and the ability to work collaboratively within a cross-functional engineering and manufacturing environment.

The role

As a Validation Engineer, you will be responsible for planning and executing validation activities associated with manufacturing equipment and fixtures, taking deliverables from protocol development through execution and final reporting.

Key responsibilities include:

• Develop validation protocols for manufacturing equipment and fixtures, including IQ, OQ and PQ activities

• Execute equipment and fixture validation protocols

• Analyze and document validation results

• Prepare clear and comprehensive validation reports

• Support additional fixture and equipment qualification activities

• Draft procedures and technical documentation related to product manufacturing and inspection

• Develop and revise procedures governing manufacturing and inspection areas

• Ensure validation documentation is accurate, complete and appropriately controlled

• Work closely with engineering, manufacturing, quality and other cross-functional stakeholders

• Plan and execute assigned validation deliverables against project requirements and timelines

• Identify and help resolve technical issues arising during validation activities

• Maintain a high level of attention to detail throughout protocol development, execution and reporting

What we're looking for

• Bachelor's degree in Engineering

• 5–7 years of relevant engineering experience

• Previous hands-on experience with equipment, fixture or process validation

• Strong experience developing and executing validation protocols

• Practical knowledge of IQ/OQ/PQ

• Experience writing validation reports and associated technical documentation

• Strong technical writing capabilities

• Experience drafting and revising manufacturing procedures, work instructions or similar controlled documentation

• Strong analytical and problem-solving skills

• Excellent written and verbal communication skills

• Strong attention to detail

• Ability to work effectively within a cross-functional team

• Proficiency with Microsoft Office

Experience supporting validation activities within a regulated manufacturing environment would be particularly valuable.

Contract details

Location: Irvine, CA
Contract: 9 months
Schedule: Standard business hours
Pay rate: Up to $59.17 per hour

If you're an experienced Validation Engineer with strong IQ/OQ/PQ, protocol development and technical writing experience, we'd like to hear from you.

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