Validation Engineer I

BEPC Inc. - Business Excellence Professional Consulting; San Jose (CA); On-site; USD 78,523 - 85,411; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Job summary

A consulting firm in California is seeking a Validation Engineer I for a contract position in medical equipment manufacturing. The ideal candidate will hold a Bachelor's degree in engineering or a related field and possess over a year of validation experience within regulated industries. Responsibilities include developing qualification protocols, executing validation tasks, and ensuring compliance with regulatory standards. Offering competitive pay between $57-$62 per hour and benefits including medical and dental insurance.

Qualifications

• Bachelor’s degree in engineering, science, or a related technical field.
• 1+ year of validation experience within a medical device or regulated industry.
• Must be able to speak, read, comprehend, and write English.

Responsibilities

• Develop equipment and fixture matrices with defined qualification requirements.
• Create detailed Installation Qualification and Operational Qualification protocols.
• Execute IQ/OQ protocols ensuring documentation integrity.
• Write and issue validation summary reports post-execution.
• Provide technical support for SOPs related to new equipment.
• Perform troubleshooting and root cause analysis.
• Ensure compliance with FDA regulations and internal policies.
• Manage validation projects including communication with stakeholders.
• Own and execute the full validation lifecycle.

Skills

Validation experience

Troubleshooting

Root cause analysis

Technical support

Document development

Education

Bachelor's degree in engineering or related field

Tools

ISO 13485

FDA 21 CFR Part 820

GMP

GAMP

Job description

Validation Engineer I

Benefits: Medical, Dental, Vision, and Life Insurance

Pay Rate: $57-$62 per hour (Paid Weekly)

Term: 6-months contract with possible extensions

Requirements: Bachelor’s degree in engineering, Science, or a related technical field, 1+ year of validation experience within a medical device, pharmaceutical, biotechnology, or other regulated industry.

NO CORP-TO-CORP CANDIDATES WILL BE CONSIDERED

BEPC does not accept C2C, C2H, or W2 referral applications.

Duties & Responsibilities

• Develop equipment and fixture matrices with defined qualification requirements in accordance with medical device regulations and client standards.
• Create detailed, compliant Installation Qualification (IQ) and Operational Qualification (OQ) protocols for manufacturing and laboratory equipment.
• Execute IQ/OQ protocols, ensuring accurate data collection, documentation integrity, and adherence to regulatory and client requirements.
• Write and issue validation summary reports following successful protocol execution.
• Provide technical support for the development and implementation of Standard Operating Procedures (SOPs) related to newly qualified equipment and fixtures.
• Perform troubleshooting, root cause analysis, and implement corrective actions to resolve validation and compliance issues.
• Ensure validation activities comply with FDA regulations, ISO 13485, GMP, GAMP, and internal policies.
• Manage multiple validation projects simultaneously, including documentation, scheduling, and communication with internal and client stakeholders.
• Own and execute the full equipment/fixture validation lifecycle, from documentation development through testing and final reporting.

Education & Experience Requirements

• Bachelor’s degree in engineering, Science, or a related technical field.
• 1+ year of validation experience within a medical device, pharmaceutical, biotechnology, or other regulated industry.
• Working knowledge of:
• ISO 13485
• FDA 21 CFR Part 820
• 21 CFR Part 11
• GMP
• GAMP
• Must be able to speak, read, comprehend, and write English.

Seniority level

Associate

Employment type

Contract

Job function

Medical Equipment Manufacturing