CQV Specialist – Pharmaceutical Manufacturing Systems

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Analyzes and designs work systems in order to support general adherence to agreed standards, in order to ensure humanely and economical production and drives continuous improvement topics.

Siemens Healthineers' PETNET Solutions stands at the forefront of the global PET radiopharmaceutical industry, embodying excellence, and unparalleled expertise. Our commitment to the consistent and timely delivery of premium-quality radiopharmaceuticals and services has solidified our reputation as the premier partner in PET imaging since our inception in 1996.

Operating more than 47 facilities worldwide, Siemens Healthineers PETNET Solutions is recognized as the largest provider of positron emission tomography (PET) radiopharmaceuticals. Annually, we distribute over 1,000,000 doses to more than 2,800 imaging centers globally. To date, our network has successfully delivered over 6,000,000 doses across the globe since 1996.

Our extensive pharmacy network, the largest of its kind, ensures unparalleled reliability, with a dose fulfillment rate exceeding 99%. Our system's robustness guarantees the successful dispensation of orders, epitomizing our commitment to reliability and confidence in service. Discover more about our capabilities at Siemens Healthineers PETNET Solutions.

Join our team now at Siemens Healthineers as a CQV Specialist Engineer – Process Implementation

Position Summary:

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, 21 CFR Part 211 and industry standards. This position supports capital projects, new product introductions, and continuous improvement initiatives across the site.

Key Responsibilities:

• Develop and execute commissioning and qualification protocols (IQ/OQ/PQ) for pharmaceutical manufacturing equipment, utilities (WFI, HVAC, compressed air), support systems, and facilities in accordance with 21 CFR Part 211 requirements.
• 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.

Qualifications:

• Bachelor’s degree in Engineering, Chemistry, or a related field.
• 3–7 years of experience in CQV or validation within the pharmaceutical industry.
• Strong working knowledge of 21 CFR Part 211, cGMP, and validation of lifecycle principles
• PET Experience or commercials operations in strongly preferred
• 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

Preferred Knowledge/Skills and Experience:

• Experience with 18F and various metal radiochemistry is preferred

• Experience in setting up, designing, and qualifying 21 CFR Part 211 facilities

• 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.