Validation Engineer I

Description

• 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.
• Develop equipment and fixture matrices with defined qualification requirements in accordance with medical device regulations and client standards.
• Own and execute the full validation lifecycle for equipment and fixtures, from documentation development through testing and final reporting.
• Manage multiple validation projects simultaneously, including documentation, scheduling, and communication with internal and client stakeholders.
• Execute IQ/OQ protocols, ensuring accurate data collection, documentation integrity, and adherence to regulatory and client requirements.
• Provide technical support for the development and implementation of Standard Operating Procedures (SOPs) related to newly qualified equipment and fixtures.
• Write and issue validation summary reports following the successful execution of IQ/OQ protocols.

Requirements

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

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

BEPC is seeking a highly motivated Validation Engineer I to ensure that products, manufacturing equipment, fixtures, and laboratory systems comply with medical device regulations and industry standards. This role requires strong knowledge of quality control and risk management principles, the ability to interpret regulatory guidelines, and strong technical documentation skills. The ideal candidate is detail-oriented, analytical, and capable of collaborating with cross-functional teams to ensure safety, reliability, and compliance within a regulated environment.

BEPC has an open position for a Validation Engineer I

• Detailed and compliant Installation Qualification (IQ) and Operational Qualification (OQ) protocols for manufacturing and laboratory equipment.
• Must be able to speak, comprehend, and write English.
• Knowledge of ISO 13485, FDA 21 CFR Part 820, Part 11, GMP, and GAMP standards related to equipment validation.
• 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.

Benefits

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

BEPC Inc., founded in 2007, is a 100% employee-owned company providing top-tier consulting and staffing solutions across industries like technology, engineering, manufacturing, and project management. At BEPC, we are driven by innovation and a commitment to excellence. We take pride in fostering a collaborative and innovative environment where our team members thrive. With competitive benefits, including medical, dental, vision, and life insurance, BEPC is dedicated to supporting our employees' personal and professional growth.

Benefits: Medical, Dental, Vision, and Life Insurance

Training + Development

Interview process

Visa Sponsorship

Security clearance