Now’s our time to inspire the future of healthcare together.
Siemens Healthineers is a leading global medical technology company with over 170 years of experience and 18,000 patents. More than 48,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. We stand with our customers around the world to support them in delivering high quality care to their patients. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services. This is what truly matters to us.
Join our team now at Siemens Healthineers as a Validation Specialist
This is a role well suited to an ambitious professional, looking for the next step in their career. As a Validation Specialist, you will play a key role in managing and developing a validation program to support new PETNET sites ensuring alignment with regulatory expectations. You will be responsible for building strong cross-functional relationships throughout the organization and translating requirements into a balanced validation program. You will also be leading new site implementation and validation activities in support of production at manufacturing sites. You will be responsible for supporting internal/external audits and other lifecycle activities as required for the validation program, included but not limited to; drafting and executing site validation master plans, drafting and managing the necessary change controls required throughout the project, gathering and managing the User Requirements for key equipment related to new site start-up, cleaning and process validations, utility, process systems and process support systems qualification test work. Finally, you will be responsible for preparing validation summary reports for the qualification and validation of systems used in manufacturing.
Other responsibilities include:
- Manage the development and maintenance of validation program documents including SOPs and Site Validation Master Plans (SVMP) for new site sites in the US.
- Developing and managing the program schedule for scheduling implementation, qualification/ validation activities of both manufacturing (cyclotron, minicells, and hot cells with ISO5 certification) and laboratory equipment (HPLC, GC, IR, IC, TLC, pH, incubators, refrigerators, freezers, Etc.) via defined calibration and IQ/OQ/PQ procedures.
- Developing and managing the list of required protocols and procedures required for new site start-up of the manufacturing and laboratory equipment.
- Managing the materials, equipment and consumable lists needed for a new site start-up
- Design and execute validation studies that are compliant with established procedures and aligned with industry best practices.
- Provide validation support in deviation investigations and change control.
- Expected to manage complex and multiple project objectives.
- Expected to contribute to regulatory filings and inspections.
- Manage project resources to accomplish defined scope of work and company goals.
- Support hosting FDA (PAI) and CMO partner inspections for new sites
- Provide validation support to over 40 PETNET Solutions sites
Required Organizational skills:
- Excellent presentation and communication skills with ability to confidently represent Manufacturing (Ops) and their assigned project in various forums and reviews.
- Excellent interpersonal skills.
- Ability to unify stakeholders in the organization around the details of the SVMP
- Able to prioritize and focus on project deliverables and quality in a rapidly changing competitive environment.
- Excellent conflict resolution skills necessary for timely decision making within the project team.
- Bachelor’s degree in Science or Engineering with 8-10 years of operational validation experience in pharmaceutical, or biotechnology industry.
- Experience in Facility, Equipment and Utility or Cleaning validation is a must (preferably in a multi-product facility).
- Process Validation experience required.
- HPLC and/or GC experience required
- Project Management or project leadership experience is a plus
- Radiopharmaceutical production experience is a plus
- Experience in supervision of internal reports and contractors are required.
- Demonstrated knowledge of cGMP compliance.
- Excellent written and oral communication skills.
- Working knowledge of Microsoft Office products (Outlook, Word, Excel, PowerPoint).
Required skills to have for the success of this role:
- Experience in facility set-up, equipment set-up, IQ/OQ/PQ, process validation, equipment acceptance testing, cyclotron operations, etc.
- Experience in performing and leading validation studies within the pharmaceutical and biotechnology industry.
- Demonstrated ability in problem solving skills and experience applying these skills to resolve technical problems.
- Minimum 10 years’ experience in the development, production and/or support of PET biomarkers used in Phase 3 clinical trials or commercial operations
- Experience managing contract manufacturing or other 3rd party client relationships
- Strong interpersonal, organizational, and managerial skills
- Excellent attention to detail in the execution of job responsibilities
- Ability to accomplish multiple tasks in fast-paced environment
- Travel as required to perform job function
Siemens Healthineers has recently announced the next steps in our continued commitment to prioritize colleague health, comply with customer/business partner requirements, and help preserve our business continuity. Going forward, please be aware that Siemens Healthineers requires full COVID-19 vaccination for all new hires by their start date.
(Note: Accommodations may be requested for certain medical or religious reasons)
At Siemens Healthineers, we value those who dedicate their energy and passion to a greater cause. Our people make us unique as an employer in the med-tech industry. What unites and motivates our global team is the inspiration of our common purpose: To innovate for healthcare, building on our remarkable legacy of pioneering ideas that translate into even better healthcare products and services. We recognize that taking ownership of our work allows both us and the company to grow. We offer you a flexible and dynamic environment and the space to move beyond your comfort zone to grow both personally and professionally.
If you want to join us in transforming the way healthcare is delivered, visit our career site at https://usa.healthcare.siemens.com/careers.
If you wish to find out more about the specific before applying, please visit: https://usa.healthcare.siemens.com/about.
As an equal-opportunity employer we are happy to consider applications from individuals with disabilities. (use your country EEO required language where applicable)
Organization: Siemens Healthineers
Company: PETNET Solutions, Inc.
Experience Level: Mid-level Professional
Job Type: Full-time
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