Lead CQV Engineer

X4 Engineering; North Carolina; Presencial; USD 144.000 - 176.000; Jornada completa

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

GMP knowledge

Documentation

Test execution

Change control

Risk assessment

Regulatory compliance

Communication

Problem solving

Project management

Educación

Bachelor's degree in engineering or related discipline

Herramientas

Microsoft Office

Descripción del empleo

An engineering services organization is seeking an experienced Commissioning, Qualification and Validation (CQV) professional to support regulated manufacturing operations in North Carolina. This role focuses primarily on CQV activities, documentation, execution and change control for manufacturing equipment, facilities, utilities and processes. You will collaborate with client engineering, manufacturing, quality and validation teams to help ensure that systems are fit for intended use and remain compliant with applicable procedures and regulatory expectations.

Key Responsibilities

• Plan, develop and execute commissioning, qualification and validation activities for equipment, utilities, facilities, manufacturing processes and applicable computerized systems.
• Work with client stakeholders to understand system requirements and prepare lifecycle documentation, including user requirements, design specifications and functional specifications.
• Develop and maintain risk assessments, validation plans, equipment classification assessments and alarm assessments to establish appropriate testing requirements.
• Review technical specifications, vendor documentation and equipment manuals to understand intended system functions and translate requirements into clear, executable test cases.
• Prepare commissioning and qualification protocols, support engineering studies, execute approved testing and document results.
• Compile final reports, qualification packages and supporting records for review and approval.
• Support investigations into deviations, failures and unexpected test results; document findings and assist with follow-up actions.
• Initiate, coordinate and own change controls, ensuring equipment, processes and facilities remain in a compliant state following modifications.
• Support the introduction and installation of new equipment from requirements and design documentation through commissioning, qualification and handover.
• Assist with improvements to existing systems where equipment performance, process changes or system modifications require reassessment or requalification.
• Prepare and update controlled GMP documentation, which may include standard operating procedures, batch records and other production support documents.
• Coordinate project actions, timelines and follow-up, communicating progress and outstanding issues to relevant client stakeholders.

Required Background

• Bachelor’s degree in engineering, manufacturing technology or a related discipline.
• Four or more years of pharmaceutical CQV, commissioning, qualification or validation experience is strongly preferred.
• Experience qualifying or validating pharmaceutical processes, equipment, utilities, facilities and/or computerized systems.
• Working knowledge of Good Manufacturing Practices (GMP), GAMP guidance, 21 CFR Part 11 and relevant FDA regulations or guidance.
• Experience authoring and executing protocols and producing clear, accurate controlled documentation and final reports.
• Understanding of change control, risk assessment, deviation investigation and validation lifecycle practices.
• Strong organizational, analytical, communication and problem-solving skills, with attention to detail.
• Ability to manage competing priorities and deadlines while working independently and collaboratively with engineering, manufacturing, quality and validation teams.
• Proficiency with Microsoft Office applications.
• Depending on the level of the position, CAPM or PMP certification may be required. Candidates who do not currently hold the applicable certification should be eligible to obtain it.

Preferred Experience

Experience in sterile pharmaceutical manufacturing or medical-device environments is advantageous, particularly in settings where equipment, processes, utilities or facilities require documented qualification and ongoing regulatory compliance.

Work Arrangement

The position is primarily onsite during the weekday day shift at client facilities in North Carolina. Occasional schedule flexibility, including evening, overnight or weekend support, may be needed to align with manufacturing operations, protocol execution, installations or troubleshooting.

Compensation & Employment

Employment type: Full-time, permanent

Base salary: Up to $160,000, depending on relevant experience and qualifications

Benefits are available; further details can be discussed during the recruitment process.