Senior CQV Engineer

Description Alliance Biotech Solutions is seeking an experienced Senior CQV Engineer with a strong engineering background to support engineering projects with a focus on facilities and utilities related capital projects at a large biopharmaceutical manufacturing facility in Holly Springs, NC. Working as part of the Global Capital Projects (CapEx) team, this individual will be responsible for independently managing commissioning, qualification, and validation (CQV) activities throughout the project lifecycle, from initial assessment and strategy development through execution and project closeout. The ideal candidate will have extensive hands-on experience with GMP facility and utility systems, and a demonstrated ability to manage projects from start to finish. This includes assessing technical challenges, developing appropriate validation strategies, coordinating engineering and quality activities, managing change controls, and driving execution to completion.

Requirements

· Lead and manage general CQV activities with an initial focus on facility and utility capital projects. · Take ownership of assigned projects throughout the full lifecycle, from initial technical assessment and validation strategy development through execution, documentation, and closeout. · Assess project requirements, identify technical challenges, and develop practical CQV strategies to address equipment, system, or facility-related issues. · Develop, coordinate, and manage project schedules, CQV execution plans, milestones, and resource priorities. · Initiate, coordinate, and manage GMP change controls, including technical impact assessments, documentation, implementation, and closure. · Review and interpret engineering drawings, including P&IDs, to evaluate system configurations, identify technical requirements, and support qualification activities. · Coordinate with engineering, facilities, quality, operations, and project management teams to ensure successful execution of project objectives. · Oversee, review, and support field commissioning and qualification activities, ensuring compliance with applicable GMP requirements and site procedures. · Identify and troubleshoot technical or project-related issues, coordinate corrective actions, and drive timely resolution. · Provide technical direction and coordination to other CQV resources and project stakeholders. · Maintain accurate project and validation documentation, communicate progress, and ensure activities remain aligned with established schedules and deliverables.

Experience/Skills

· Significant experience in commissioning, qualification, and validation within GMP-regulated pharmaceutical or biotechnology manufacturing environments. · Strong engineering background with demonstrated experience supporting facilities and utility systems. · Direct experience with pharmaceutical water systems, including WPU and WFI, and associated commissioning and qualification activities. · Proven ability to independently manage CQV projects from initial planning and validation strategy development through execution and closeout. · Experience developing and managing project schedules, coordinating resources, and driving project deliverables. · Demonstrated experience managing GMP change controls and associated technical documentation. · Ability to assess technical problems, develop appropriate validation strategies, and independently execute solutions. · Experience collaborating with cross-functional engineering, facilities, quality, and operations teams. · Strong organizational, communication, technical problem-solving, and project management skills. · Self-motivated, results-oriented approach with the ability to take ownership of projects and work effectively with minimal supervision.

Benefits & Compensation

• Industry competitive wage as a full-time employee
• Flexible Paid Time Off
• Bonus plans
• Medical, Dental and Vision Insurance with low employee cost
• Employer paid long term and short-term disability
• 401k plan with employer contributions

About Alliance Biotech Solutions

Alliance Biotech Solutions (ABS) is a premier consulting firm specializing in biopharmaceutical engineering and validation services. As industry leaders in Commissioning, Qualification, and Validation (CQV), we provide crucial services to the biotech and pharmaceutical sectors while maintaining our philosophy that employees are our #1 priority. Our success is built on the foundation of empowering our team members' growth and development, recognizing that our employees are the cornerstone of our clients' success. Alliance Biotech Solutions is an Equal Employment Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, ancestry, citizenship status, military status, protected veteran status, religion, creed, physical or mental disability, medical condition, marital status, sex, sexual orientation, gender, gender identity or expression, age, genetic information, or any other basis protected by law, ordinance, or regulation. Alliance Biotech Solutions does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Alliance Biotech Solutions, and Alliance Biotech Solutions will not be obligated to pay a placement fee. All persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.