Senior Validation Engineer - 175500

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

Benefits offered by this job

Medical

Dental

Vision

Sick leave

401K

Job summary

Piper Companies is seeking a Senior Validation Engineer to join a rapidly growing biopharma manufacturing organization on an onsite contract in Clayton, NC. The role leads validation for automated manufacturing systems, equipment, and processes within a GMP environment.

The ideal candidate has a strong background in FDA regulations, 21 CFR Part 11, and CSV, with 7+ years in validated settings. You will drive IV/OV/PV activities, change controls, and cross-functional collaboration to keep

Qualifications

• Bachelor's degree in Engineering, Computer Science, or a related field.
• 7+ years of validation experience in regulated manufacturing (pharma/biotech/medical devices).
• Strong knowledge of GMP, FDA regulations, 21 CFR Part 11, GAMP 5, ICH guidelines.
• Experience with automated manufacturing equipment validation and change control.
• Proven leadership to manage multiple initiatives and cross-functional teams.

Responsibilities

• Lead IV, OV, and PV protocol development, execution, analysis, and reporting.
• Manage validation change controls and document reviews to meet standards.
• Author validation plans and supporting quality records.
• Investigate deviations with root cause analysis.
• Coordinate FAT, SAT, commissioning, and startup activities with stakeholders.

Skills

GMP knowledge

Project leadership

Root cause investigation

Education

Bachelor's degree in Engineering/CS

Job description

Piper Companies is seeking a Senior Validation Engineer to join a rapidly growing biotechnology manufacturing organization for an onsite contract position located in Clayton, NC. The Senior Validation Engineer will lead validation activities for automated manufacturing systems, equipment, and processes while supporting large-scale pharmaceutical production projects in a regulated GMP environment.

Responsibilities of the Senior Validation Engineer include:

• Lead the development, execution, analysis, and reporting of Installation Verification (IV), Operational Verification (OV), and Performance Verification (PV) protocols for manufacturing equipment and processes.
• Manage validation-related change controls, review protocol documentation, and ensure all activities meet regulatory and site quality standards.
• Author and maintain validation plans, project quality documentation, procedures, specifications, and supporting records required to sustain a validated state.
• Drive investigations associated with validation deviations, failures, and nonconformances using structured root cause analysis methodologies.
• Support FAT, SAT, commissioning, and startup activities while coordinating validation project schedules, contractors, and cross-functional stakeholders.

Qualifications for the Senior Validation Engineer include:

• Bachelor's degree in Engineering, Computer Science, or a related technical discipline; advanced degree preferred.
• 7+ years of validation experience within pharmaceutical, biotechnology, medical device, or other highly regulated manufacturing environments.
• Strong knowledge of GMP requirements, FDA regulations, 21 CFR Part 11, GAMP 5, ICH guidelines, and computerized system validation principles.
• Demonstrated experience with automated manufacturing equipment validation, change management, and complex root cause investigations.
• Proven project leadership skills with the ability to manage multiple initiatives, technical documentation, timelines, and cross-functional teams.

Compensation for the Senior Validation Engineer:

Salary Range: $74-$84/hr (USD)

• Comprehensive Benefits: Medical, Dental, Vision, sick leave if required by law, and 401K

This job opens for applications on 9/30/26. Applications for this job will be accepted for at least 30 days from the posting date.

Keywords: validation engineer, process validation, equipment validation, computerized systems validation, CSV, GMP, pharmaceutical manufacturing, biotechnology, FDA compliance, 21 CFR Part 11, GAMP5, change control, deviation investigation, CAPA, root cause analysis, commissioning, FAT, SAT, IQ, OQ, PQ, automation systems, quality assurance, validation protocols, technical writing, project management, manufacturing processes, regulatory compliance, SOP development, engineering validation, quality systems, process improvement, biotech manufacturing.

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