CQV Specialist – Pharmaceutical Manufacturing Systems

Siemens Healthineers

100d • $116,500 - $174,700

About The Position

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions. The CQV Specialist plays a critical role in ensuring that pharmaceutical manufacturing systems—including equipment, utilities, facilities, and processes—are commissioned, qualified, and validated in compliance with cGMP regulations and industry standards. This position supports capital projects, new product introductions, and continuous improvement initiatives across the site.

Requirements

• Bachelor’s degree in Engineering, Chemistry, or a related field.
• 3–7 years of experience in CQV or validation within the pharmaceutical industry.
• Strong understanding of cGMP, FDA/EMA regulations, and validation lifecycle principles.
• Experience with pharmaceutical manufacturing equipment (e.g., granulators, tablet presses, autoclaves, filling lines).
• Familiarity with cleanroom environments and aseptic processing.
• Excellent technical writing and communication skills.
• Ability to work independently and manage multiple priorities in a fast-paced environment.
• Up to 50% travel, as required, to perform job functions.

Nice To Haves

• Experience with 18F radiochemistry is preferred; training will be provided to an otherwise well-qualified candidate.
• Experience with general radiation safety and hazardous material handling or similar technical experience.
• Experience working with complex analytical equipment such as HPLC, GC and TLC.
• Experience with risk-based validation approaches (e.g., ASTM E2500).
• Knowledge of ISPE Baseline Guides and GAMP 5.
• Proficiency in computerized system validation (CSV) and data integrity compliance.
• Project management experience in capital projects or tech transfers.

Responsibilities

• Develop and execute commissioning and qualification protocols (IQ/OQ/PQ) for pharmaceutical manufacturing equipment, clean utilities (WFI, HVAC, compressed air), and support systems.
• Author and review validation documentation including Validation Master Plans (VMP), risk assessments, and summary reports.
• Collaborate with Engineering, Quality Assurance, and Manufacturing teams to ensure timely and compliant CQV execution.
• Support Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), and system turnover processes.
• Ensure alignment with regulatory requirements (FDA, EMA, ICH Q8/Q9/Q10) and internal quality standards.
• Participate in deviation investigations, change control processes, and CAPA implementation related to CQV activities.
• Maintain validation documentation in accordance with cGMP and data integrity principles.
• Provide support during internal and external audits and regulatory inspections.

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• 401(k) retirement plan
• Life insurance
• Long-term and short-term disability insurance
• Paid parking/public transportation
• Paid time off
• Paid sick and safe time

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees