Validation Engineer

The Validation Engineer will play a crucial role in commissioning and qualification efforts for equipment, utilities, and processes. This position requires consulting with site technical services for process and cleaning validation, while reporting to the Director of Manufacturing Engineering.

Responsibilities

• Lead all validation activities and maintain the validation master plan for the site.
• Manage and/or lead the validation team in all CQV activities to meet site goals and timelines.
• Create commissioning, qualification, and validation documentation, including user requirement specification, design qualification, protocols, and final summary reports.
• Conduct commissioning, qualification, and validation according to approved corporate standards and protocols.
• Collaborate with the system owner to define user requirements and establish an appropriate CQV strategy.
• Support quality systems such as change control, deviations, CAPA, audits, quality metrics, and annual product reviews.

Essential Skills

• Proven experience in pharmaceutical and biotech environments.
• Expertise in validation testing and protocols.
• Knowledge in process validation and equipment validation.
• Excellent technical writing skills.

Additional Skills & Qualifications

• Bachelor's or Master's degree in a scientific discipline or related field.
• Minimum of 5 years of experience in commissioning, qualification, and validation of cGMP or cGXP.
• Specific knowledge of biological and pharmaceutical cGMPs (USDA and EU).
• Strong verbal, written, interpersonal, organizational, and communication skills.