Advanced Accelerator Applications (Italy) - S...
Commissioning & Qualification (C&Q) Engineering Lead (RLT, Carlsbad)
Advanced Accelerator Applications (Italy) - S..., Carlsbad, California, United States, 92002
Commissioning & Qualification (C&Q) Engineering Lead (RLT, Carlsbad)
Job ID: REQ-10004943Date: Apr 30, 2024Location: USASummary
The C&Q Engineering Lead (RLT, Carlsbad) is responsible for executing and managing equipment, facility, utility, process, and primary packaging validation activities to meet cGMP requirements on time and quality. This ensures that site validation programs comply with global regulatory expectations and supports current project operations and site goal objectives.About the Role
At Advanced Accelerator Applications, a Novartis company, we are committed to leading innovation in nuclear medicine and delivering targeted radioligand therapy to cancer patients. We are looking for experienced Supply Chain professionals to help us reach our ambitious goals.
Location: OnsiteYour responsibilities include, but are not limited to:Lead site C&Q planning by writing and maintaining master plans for projects and the site including equipment, facility, utilities, processes, packaging processes, and ongoing verification for processes and cleaning (as applicable).Maintain the site process control strategy.Draft CQV and CSV activities for production and manufacturing equipment.Support ongoing qualification activities of VHP qualification, smoke studies, temperature mapping, room qualification, and requalification.Design, execute, and document experiments (formulation/analytical tests, etc.) for products assigned in the context of process transfer, process improvement, and process validation.Prepare and review appropriate GxP documentation including change requests.Identify improvement options for current processes and propose business cases.The pay range for this position at commencement of employment is expected to be between $124,000 and $186,000 per year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards, in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered.Minimum Requirements
Bachelor's degree is required; Master's Degree is preferred, preferably in Chemical or Mechanical Engineering.5+ years of relevant experience in a GMP pharma environment is required.Experience in executing CQV and managing validation projects is required.Direct experience in an aseptic manufacturing setting is highly preferred.Expert in reviewing and writing technical reports.Why Advanced Accelerator Applications?
Thousands of people die of cancer around the world every day. At Advanced Accelerator Applications, a Novartis company, our mission is to transform lives through radioligand therapy in nuclear medicine to fight several leading types of cancer. We believe new groundbreaking solutions can be found at the intersection of medical science and digital innovation, and that a diverse, equitable, and inclusive environment inspires new ways of working.Commitment to Diversity & Inclusion
Novartis embraces diversity, equal opportunity, and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration.Accessibility & Reasonable Accommodations
The Novartis Group of Companies is committed to working with and providing reasonable accommodation to individuals with disabilities. If you need a reasonable accommodation for any part of the application process, please send an e-mail to us.reasonableaccommodations@novartis.com or call +1(877)395-2339.
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Job ID: REQ-10004943Date: Apr 30, 2024Location: USASummary
The C&Q Engineering Lead (RLT, Carlsbad) is responsible for executing and managing equipment, facility, utility, process, and primary packaging validation activities to meet cGMP requirements on time and quality. This ensures that site validation programs comply with global regulatory expectations and supports current project operations and site goal objectives.About the Role
At Advanced Accelerator Applications, a Novartis company, we are committed to leading innovation in nuclear medicine and delivering targeted radioligand therapy to cancer patients. We are looking for experienced Supply Chain professionals to help us reach our ambitious goals.
Location: OnsiteYour responsibilities include, but are not limited to:Lead site C&Q planning by writing and maintaining master plans for projects and the site including equipment, facility, utilities, processes, packaging processes, and ongoing verification for processes and cleaning (as applicable).Maintain the site process control strategy.Draft CQV and CSV activities for production and manufacturing equipment.Support ongoing qualification activities of VHP qualification, smoke studies, temperature mapping, room qualification, and requalification.Design, execute, and document experiments (formulation/analytical tests, etc.) for products assigned in the context of process transfer, process improvement, and process validation.Prepare and review appropriate GxP documentation including change requests.Identify improvement options for current processes and propose business cases.The pay range for this position at commencement of employment is expected to be between $124,000 and $186,000 per year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards, in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered.Minimum Requirements
Bachelor's degree is required; Master's Degree is preferred, preferably in Chemical or Mechanical Engineering.5+ years of relevant experience in a GMP pharma environment is required.Experience in executing CQV and managing validation projects is required.Direct experience in an aseptic manufacturing setting is highly preferred.Expert in reviewing and writing technical reports.Why Advanced Accelerator Applications?
Thousands of people die of cancer around the world every day. At Advanced Accelerator Applications, a Novartis company, our mission is to transform lives through radioligand therapy in nuclear medicine to fight several leading types of cancer. We believe new groundbreaking solutions can be found at the intersection of medical science and digital innovation, and that a diverse, equitable, and inclusive environment inspires new ways of working.Commitment to Diversity & Inclusion
Novartis embraces diversity, equal opportunity, and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration.Accessibility & Reasonable Accommodations
The Novartis Group of Companies is committed to working with and providing reasonable accommodation to individuals with disabilities. If you need a reasonable accommodation for any part of the application process, please send an e-mail to us.reasonableaccommodations@novartis.com or call +1(877)395-2339.
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