Senior CQV Engineer - Onsite GMP Validation (NC)

X4 Engineering; North Carolina; On-site; USD 144,000 - 176,000; Full time

Job summary

X4 Engineering is seeking an experienced Commissioning, Qualification and Validation (CQV) professional to support regulated manufacturing operations in North Carolina. This role focuses on CQV activities, documentation, execution and change control for equipment, facilities, utilities and processes.

You will collaborate with client engineering, manufacturing, quality and validation teams to ensure systems are fit for intended use and compliant with GMP, GAMP, 21 CFR Part 11 and FDA guidance.

Qualifications

• Bachelor's degree in engineering or related discipline.
• Four or more years of pharmaceutical CQV, commissioning, qualification or validation experience.
• Experience qualifying or validating pharmaceutical processes, equipment, utilities, facilities and/or computerized systems.
• Working knowledge of GMP, GAMP guidance, 21 CFR Part 11 and FDA guidance.
• Experience authoring and executing protocols and producing controlled documentation and final reports.
• Understanding of change control, risk assessment, deviation investigation and validation lifecycle practices.

Responsibilities

• Plan, develop and execute commissioning, qualification and validation activities for equipment, utilities, facilities and processes.
• Prepare lifecycle documentation including user requirements, design specifications and functional specs.
• Develop risk assessments, validation plans and alarm assessments to establish testing requirements.
• Review vendor docs and translate requirements into executable test cases.
• Prepare protocols, support testing and document results; compile reports and records.
• Support investigations into deviations and assist with follow-up actions.
• Initiate and coordinate change controls to maintain compliance after modifications.
• Assist with installation of new equipment from requirements through handover.

Skills

GMP knowledge

Documentation

Test execution

Change control

Risk assessment

Regulatory compliance

Communication

Problem solving

Project management

Education

Bachelor's degree in engineering or related discipline

Tools

Microsoft Office

Job description

X4 Engineering is seeking an experienced Commissioning, Qualification and Validation (CQV) professional to support regulated manufacturing operations in North Carolina. This role focuses on CQV activities, documentation, execution and change control for equipment, facilities, utilities and processes.

You will collaborate with client engineering, manufacturing, quality and validation teams to ensure systems are fit for intended use and compliant with GMP, GAMP, 21 CFR Part 11 and FDA guidance.