Onsite Senior Validation Engineer – GMP Biotech Automation

Piper Companies; Clayton (NC); On-site; USD 102,000 - 116,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401K

Job summary

Piper Companies is seeking a Senior Validation Engineer to join a rapidly growing biotechnology manufacturing organization on an onsite contract in Clayton, NC. The Senior Validation Engineer will lead validation activities for automated manufacturing systems, equipment, and processes in a regulated GMP environment.

Responsibilities include developing, executing, analyzing, and reporting IV, OV, and PV protocols; managing change controls; authoring validation plans and quality records; and

Qualifications

• Bachelor's degree in Engineering, Computer Science, or related field required.
• 7+ years of validation experience in regulated manufacturing environments.
• Strong knowledge of GMP, FDA regulations, 21 CFR Part 11, GAMP 5, ICH guidelines, and CSV principles.
• Experience with automated manufacturing equipment validation, change management, and investigations.
• Proven ability to lead multiple initiatives and cross-functional teams with strong documentation practices.

Responsibilities

• Lead IV, OV, and PV protocol development, execution, analysis, and reporting for manufacturing equipment and processes.
• Manage validation-related change controls and ensure compliance with regulatory and site quality standards.
• Author and maintain validation plans, project quality documents, procedures, specifications, and supporting records.
• Drive investigations for validation deviations, failures, and nonconformances using root cause analysis.
• Support FAT, SAT, commissioning, startup activities and coordinate validation project schedules with stakeholders.

Skills

Validation experience

Regulatory compliance

Project leadership

Root cause analysis

Documentation

Education

Bachelor's degree in Engineering, Computer Science, or related field

Job description

Piper Companies is seeking a Senior Validation Engineer to join a rapidly growing biotechnology manufacturing organization on an onsite contract in Clayton, NC. The Senior Validation Engineer will lead validation activities for automated manufacturing systems, equipment, and processes in a regulated GMP environment.

Responsibilities include developing, executing, analyzing, and reporting IV, OV, and PV protocols; managing change controls; authoring validation plans and quality records; and