Validation Engineer I

BEPC Inc. - Business Excellence Professional Consulting; Santa Clara (CA); On-site; USD 82,656 - 85,411; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Job summary

A consulting and staffing solutions company is seeking a Validation Engineer I in Santa Clara, CA. This role requires at least 1 year of validation experience in a medical device or pharmaceutical industry. Responsibilities include developing qualification matrices, preparing and executing IQ/OQ protocols, and ensuring compliance with FDA regulations. The position offers a contract term of 6 months with possible extensions and is backed by competitive benefits including medical, dental, vision, and life insurance.

Qualifications

• 1+ years of experience as a Validation Engineer in a regulated industry.
• Knowledge of FDA and MDD GMP requirements related to medical devices.
• Experience with equipment validation standards.

Responsibilities

• Develop equipment and fixture matrices in compliance with regulations.
• Prepare and execute IQ/OQ protocols for equipment.
• Write validation summary reports after protocol execution.
• Perform troubleshooting and corrective actions for compliance issues.
• Manage multiple validation projects and communications with stakeholders.

Skills

ISO 13485

Validation experience

English proficiency

FDA regulations knowledge

Education

Bachelor’s degree in Engineering, Science, or related field

Job description

BEPC has an open position for a Validation Engineer I.

Benefits: Medical, Dental, Vision, and Life Insurance.

Pay Rate: $60-$62 per hour (determined based on experience).

Term: 6-month contract with possible extensions.

Requirements: 1+ years of experience as a Validation Engineer in a medical device, pharmaceutical, or similarly regulated industry.

Experience with Validation and ISO 13485, with demonstrated knowledge of FDA and MDD GMP requirements related to Medical Devices or Pharm.

Note: This is a W2 only role — C2C, C2H will not be considered.

Seniority Level: Associate. Employment Type: Contract. Job Function: Manufacturing.

Responsibilities

• Develop equipment and fixture matrices with defined qualification requirements in accordance with medical device regulations and client standards.
• Prepare detailed and 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 the successful execution of IQ/OQ protocols.
• 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 corrective action implementation to resolve validation and compliance issues.
• Ensure all validation activities comply with FDA regulations, ISO 13485, GMP, and internal policies.
• Manage multiple validation projects simultaneously, including documentation, scheduling, and communication with internal and client stakeholders.
• Own and execute the full validation lifecycle for equipment and fixtures, from documentation development through testing and final reporting.

Qualifications

• Bachelor’s degree in Engineering, Science, or a related technical field.
• 1 year of validation experience within a medical device, pharmaceutical, biotechnology, or similar regulated industry.
• Knowledge of ISO 13485, FDA 21 CFR Part 820, Part 11, GMP, and GAMP standards related to equipment validation.
• Must be able to speak, comprehend, and write English.

About BEPC

BEPC Inc., founded in 2007, is a 100% employee‑owned company providing top‑tier consulting and staffing solutions across industries such as technology, engineering, manufacturing, and project management. BEPC is driven by innovation and a commitment to excellence, fostering a collaborative environment where employees thrive. Competitive benefits, including medical, dental, vision, and life insurance, support employees’ personal and professional growth.

Location

Santa Clara, CA.

How to Apply

Qualified candidates are encouraged to submit an up‑to‑date resume that highlights how your experience aligns with the role. Please include specific examples that demonstrate your qualifications. We look forward to connecting with you!