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.

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 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, 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.

Qualifications:

Bachelor’s degree in Engineering, Chemistry, or a related field.3–7 years of experience in CQV or validation within the pharmaceutical industry.PET Experience or commercials operations in strongly preferredStrong 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

Preferred Knowledge/Skills and Experience:

Experience with 18F radiochemistry is preferred; training will be provided to an otherwise well-qualified candidateExperience with general radiation safety and hazardous material handling or similar technical experienceExperience working with complex analytical equipment such as HPLC, GC and TLCExperience 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.

Who we are: We are a team of more than 73,000 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.

To find out more about Siemens Healthineers businesses, please visit our company page here.

The annual base pay for this position is:

Min $116,500 - Max $174,700

Factors which may affect starting pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate.

If this is a commission eligible position the commission eligibility will be in accordance with the terms of the Company's plan. Commissions are based on individual performance and/or company performance.

The Company offers the following benefits for this position, subject to applicable eligibility requirements: 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.

Equal Employment Opportunity Statement: Siemens Healthineers is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.

EEO is the Law: Applicants and employees are protected under Federal law from discrimination.

Reasonable Accommodations: Siemens Healthineers is committed to equal employment opportunity. As part of this commitment, we will ensure that persons with disabilities are provided reasonable accommodations.

If you require a reasonable accommodation in completing a job application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please fill out the accommodations form here. If you’re unable to complete the form, you can reach out to our HR People Connect People Contact Center for support at peopleconnectvendorsnam.func@siemens-healthineers.com. Please note HR People Connect People Contact Center will not have visibility of your application or interview status.

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Export Control: “A successful candidate must be able to work with controlled technology in accordance with US export control law.” “It is Siemens Healthineers’ policy to comply fully and completely with all United States export control laws and regulations, including those implemented by the Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations.”

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