Siemens Healthineers
Quality Lead – Facilities, Engineering & Validation (f/m/d)
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Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.
At Siemens Healthineers (SHS) Radiopharma, we are committed to driving sustainable progress through cutting-edge technology. We empower our customers by bridging the physical and digital worlds—enhancing the way we live, work, and move, today and for future generations.
We believe that business success begins with our people. That’s why we prioritize a culture where individuals thrive. Our diverse team is ready to support, inspire, and challenge you to grow in new and meaningful ways. Together, there are limitless possibilities of where our shared journey may lead.
As the global leader in the supply of positron emission tomography (PET) radiopharmaceuticals, SHS Radiopharma pioneered the commercial PET radiopharmacy model over 30 years ago—and continues to shape the future of molecular imaging.
Join us as a Quality Lead – Facilities, Engineering & Validation, where you will provide Quality leadership for the design, construction, qualification, validation, and operational readiness of PET radiopharmaceutical manufacturing facilities across the Siemens Healthineers Radiopharma network. You will ensure that new facilities, production lines, and major upgrades comply with cGMP, EU GMP Annex 1, regulatory requirements, and Siemens Healthineers Quality standards. Working closely with Project Management, Technical Operations, Quality, Engineering, Regulatory Affairs, and external partners, you will support projects from initial design through commissioning, validation, regulatory inspections, and successful handover to routine GMP operations.
Location: Saint-Genis-Pouilly (France), Lisses (France), Barcelona (Spain), Dunstable (United Kingdom), Munich (Germany) or Colleretto Giacosa (Italy).
Type of contract: Permanent
Your Role
- Act as the International Quality Lead and Subject Matter Expert for new PET radiopharmaceutical manufacturing facilities, facility expansions, new production lines, and major facility or equipment upgrade projects across the Radiopharma network.
- Provide Quality oversight throughout the entire project lifecycle, from concept and facility design through construction, commissioning, qualification, validation, regulatory approval, and operational handover.
- Ensure GMP, Quality, and regulatory requirements are integrated into facility and process design through Quality-by-Design principles, design reviews, and risk assessments, identifying and mitigating compliance risks at the earliest stages.
- Define and oversee Commissioning, Qualification & Validation (CQV) strategies for facilities, equipment, utilities, computerized systems, and manufacturing processes, including URS, DQ, FAT, SAT, IQ, OQ, PQ, process validation, and GMP release activities.
- Review and approve Validation Master Plans, protocols, reports, deviations, change controls, risk assessments, and all supporting qualification and validation documentation.
- Serve as the Quality expert for aseptic processing and Vaporized Hydrogen Peroxide (VHP) technologies, supporting system design, cycle development, qualification, validation, routine operations, performance monitoring, requalification activities, and contamination control strategies.
- Provide Quality oversight for the selection, qualification, and implementation of critical manufacturing and QC equipment, including cyclotrons, target systems, hot cells, isolators, synthesis modules, dispensing systems, VHP/decontamination systems, HVAC, environmental monitoring systems, critical utilities, laboratory equipment, and automated GMP systems.
- Lead GMP readiness activities for new facilities and production lines, ensuring completion of qualification and validation programs, SOP implementation, training, process validation, equipment release, Quality System readiness, and inspection preparedness.
- Support Health Authority inspections, customer audits, and regulatory assessments associated with new facilities, expansions, and manufacturing start-up activities.
- Develop and drive harmonized Quality standards, validation methodologies, templates, and best practices across the international Radiopharma network, leveraging lessons learned to reduce regulatory risk and accelerate future facility start-ups.
- Conduct site visits, project reviews, and cross-functional assessments to monitor project execution, identify risks, ensure compliance, and promote consistency across all facility projects.
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Job Dimensions
Geographical Scope
Responsibility across the Siemens Healthineers Radiopharma International network, including the United Kingdom, Portugal, Spain, Switzerland, France, Italy, Germany, and India.
Leadership
No direct reports initially; ability to lead through influence, cross-functional collaboration, project leadership, and matrix management is essential.
Financial Responsibility
Oversight of Quality-related project expenditures and CAPEX activities, ensuring alignment with approved project budgets and business objectives.
Travel
Significant international travel required to support facility design reviews, vendor audits and activities, FAT/SAT execution, CQV programs, regulatory inspections, GMP readiness, and facility start-up activities.
Key Stakeholders
Close collaboration with Quality, Technical Operations, Strategic Project Management, Engineering, Regulatory Affairs, Operations, HSE, Finance, Site Leadership teams, external engineering partners, equipment suppliers, and other key stakeholders across the international network.
Work Experience
Your profile:
- Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences, Engineering, Chemistry, Life Sciences, or a related scientific discipline. Advanced qualifications are considered an asset.
- Fluent in English, both written and spoken. Additional European languages are a plus.
- At least 8 years of experience in Quality, Validation, Engineering, Technical Operations, or Manufacturing within the pharmaceutical, radiopharmaceutical, biotechnology, or other GMP-regulated industries.
- Proven experience working within aseptic manufacturing environments and a strong understanding of cGMP requirements, particularly EU GMP Annex 1 and contamination control principles.
- Demonstrated involvement in the design, construction, qualification, validation, and start-up of GMP manufacturing facilities or major facility expansion projects.
- Strong expertise in Commissioning, Qualification & Validation (CQV), including the development, review, and approval of URS, DQ, FAT, SAT, IQ, OQ, PQ, process validation, and validation lifecycle documentation.
- Hands-on experience with cleanroom environments, HVAC systems, environmental monitoring, critical utilities, isolators, hot cells, and other GMP manufacturing technologies.
- Solid knowledge of Quality Risk Management, deviation investigations, CAPA, change control, and regulatory inspection readiness.
- Experience supporting Health Authority inspections and the regulatory approval of new or significantly modified manufacturing facilities.
- Ability to collaborate effectively with engineering firms, equipment suppliers, project teams, and cross-functional stakeholders in a complex international environment.
- Strong project leadership, communication, and stakeholder management skills, with the ability to influence and drive decisions within a matrix organization.
- Willingness to travel internationally on a regular basis.
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Preferred Qualifications
- Experience in PET radiopharmaceutical manufacturing and familiarity with the specific requirements of short half-life products and radiation-controlled environments.
- Practical expertise with Vaporized Hydrogen Peroxide (VHP) systems, including design review, cycle development, qualification, validation, and routine operation.
- Direct experience bringing a new PET or sterile pharmaceutical manufacturing facility from design through GMP approval and commercial production.
- Exposure to cyclotrons, synthesis modules, dispensing systems, isolators, hot cells, Annex 1 remediation projects, greenfield or brownfield facility construction, and regulatory inspections of newly commissioned facilities.
Benefits
Who we are:
We are a team of more than 74,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.
How We Work
When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world’s most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Check our Careers Site at Jobs at Siemens Healthineers AG.
As an equal opportunity employer, we welcome applications from individuals with disabilities.
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Siemens Healthineers' recruitment is internally managed, with external support permitted only when a qualified supplier has established a formal contract with us. Unsolicited candidate submissions and referrals, absent a current supplier contract, do not establish consent and are ineligible for fees. We delete and destroy unsolicited information, thus, would recommend you refrain from any such practices. Your adherence to our policies is appreciated.
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