Validation Engineer (Medical Devices)

Validation Engineer – Medical Device Industry

BEPC Inc. is seeking a qualified Validation Engineer to support validation activities within a regulated medical device manufacturing environment. This position will be responsible for developing, executing, and documenting validation protocols to ensure that manufacturing equipment and processes comply with quality, regulatory, and operational requirements.

Key Responsibilities

• Develop, execute, and document Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
• Prepare validation plans, protocols, reports, and supporting technical documentation.
• Coordinate validation activities for manufacturing equipment, processes, and production lines.
• Analyze validation results and ensure that all acceptance criteria are successfully met.
• Investigate protocol deviations and support the implementation of corrective actions.
• Collaborate with Manufacturing, Quality, Engineering, and other cross-functional teams.
• Support equipment installation, process changes, product transfers, and new product introductions.
• Maintain complete and accurate validation documentation in accordance with Good Documentation Practices.
• Ensure compliance with applicable medical device quality systems, procedures, and regulatory requirements.
• Provide validation support during internal and external audits, as required.

Mandatory Requirements

• Bachelor’s degree in Engineering or a related technical field.
• Professional experience in the medical device industry is mandatory .
• Hands-on experience developing, executing, or documenting IQ, OQ, and PQ protocols .
• Knowledge of validation principles and regulated manufacturing environments.
• Experience preparing technical reports and controlled documentation.
• Ability to analyze data, investigate deviations, and solve technical problems.
• Strong organizational skills and attention to detail.
• Ability to collaborate effectively with cross-functional teams.
• English proficiency sufficient to understand and prepare technical documentation.

Preferred Qualifications

• Experience with process, equipment, or manufacturing validation.
• Knowledge of GMP, Good Documentation Practices, change control, CAPA, risk analysis, and statistical methods.
• Experience with document-control or quality-management systems such as Windchill.
• Experience supporting medical device manufacturing transfers or new product introductions.