Senior Pharmaceutical Quality Engineer
3 months ago
Lantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio.
Lantheus is an entrepreneurial, agile, growing organization that provides innovative diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions that empower clinicians to find, fight and follow disease. At Lantheus our purpose and values guide our behaviors in all interactions and play a vital role in creating a dynamic environment that contributes to our success. Every employee is crucial to our success; we respect one another and act as one knowing that someone’s health is in our hands. We believe in helping people be their best and are seeking to bring together a diverse group of individuals with different viewpoints and skill sets to be a part of a productive and inclusive team.
Summary
The Senior Pharmaceutical Quality Engineer is a technical professional that participates in the development, implementation, and evaluation of processes, procedures, and applications with the overall objective of providing Quality oversight for routine manufacturing of aseptically filled, radiopharmaceutical products produced by Contract Manufacturing Organizations (CMO). Provide Quality Assurance technical expertise to ensure aseptic manufacturing, processes and support systems are in compliance with company guidelines and CGMP regulations for products and/or their raw materials, APIs, excipients or components.
Key Responsibilities/Essential Functions
- Function as the primary QA representative in CMO change management, investigation and CAPA review and approval, while adhering to regulatory, technical and business requirements.
- Provide quality oversight of routine Manufacturing operations, by gathering and reviewing information from functional areas and identifying compliant solutions based on evidence utilizing a risk-based approach.
- Collaborate with full range of personnel in manufacturing and technical work teams, both internal and external, that support Production to ensure product SISPQ are met.
- Provide leadership and technical expertise in conducting CMO investigations by utilizing root cause analysis tools to determine root cause(s), implementing corrective and preventative actions (CAPA) to prevent reoccurrence and assessment of product/patient impact.
- Serve as the primary Quality representative for management of CMO Supplier Change Notification records.
- Represent QA in a range of team meetings, processes and initiatives both internally and with CMOs.
- Function as the primary QA representative for CMO metric management, including trending and reporting.
- Review and approve protocols, validation documents and procedures, both internally and externally.
- Act as technical resource with the FDA and other government agencies during site inspections.
- Alert management of critical issues that have significant impact to manufacturing objectives and timelines, while providing a range of achievable solutions.
- Support Investigation Review Board and Change Control Review Board meetings as required.
- Remain current and apply knowledge of FDA CFR 210/211 and other regulatory standards and guidance in the pharmaceutical industry.
Basic Qualifications
- BS/BA degree in a scientific discipline with minimum 5 years of progressive experience in the pharmaceutical or radiopharmaceutical industry or related GMP environment, or equivalent.
Other Requirements
- Aseptic fill-finish experience, including familiarity with validation of aseptic manufacturing technologies and facilities is preferred.
- Previous lab experience in Manufacturing and/or Quality Control at aseptic processing facility is preferred.
- Previous experience in Quality, Compliance and/or Manufacturing of radiopharmaceutical products is preferred.
- Handling of and, or exposure to potentially hazardous chemical, radiological and or biological materials. Required to follow all safety procedures, and use personal and protective equipment provided.
- Ability to travel up to 20%.
Core Values
The ideal candidate will embody Lantheus core values:
- Let people be their best
- Respect one another and act as one
- Learn, adapt, and win
- Know someone’s health is in our hands
- Own the solution and make it happen
Lantheus is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Lantheus is an E-Verify Employer in the United States. Lantheus will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Lantheus Talent Acquisition team at talentacquisition@lantheus.com.
#LI-HYBRID
-
Senior Pharmaceutical Engineer
1 week ago
Indianapolis, Indiana, United States Catalyst Life Sciences Full timeCatalyst Life Sciences is seeking a Senior Chemical Engineer to join our dynamic team. This role is pivotal within a prominent pharmaceutical organization.Key Qualifications:PhD in Chemical Engineering is essential.Demonstrated experience in the pharmaceutical sector.Expertise in small molecule development is required.The ideal candidate will contribute...
-
Senior Chemical Engineer
22 hours ago
Indianapolis, Indiana, United States Catalyst Life Sciences Full timeWe are seeking a highly experienced Senior Chemical Engineer to join our team at Catalyst Life Sciences. As a key member of our organization, you will be responsible for leading the development and implementation of chemical engineering solutions for our pharmaceutical clients.Key Responsibilities:Develop and implement chemical engineering solutions for...
-
Indianapolis, Indiana, United States Lantheus Medical Imaging Inc Full timeJob OverviewLantheus Medical Imaging Inc., a leader in the medical imaging sector, is seeking a Senior Pharmaceutical Quality Engineer to enhance our quality assurance capabilities. With a legacy of over 60 years, we are dedicated to advancing patient care through innovative diagnostics and therapeutic solutions.Position SummaryThe Senior Pharmaceutical...
-
Indianapolis, Indiana, United States Lantheus Medical Imaging Inc Full timeJob OverviewLantheus Medical Imaging Inc., a leader in the medical imaging sector, is seeking a Senior Pharmaceutical Quality Engineer. This role is pivotal in ensuring the quality and compliance of our aseptically filled radiopharmaceutical products manufactured by Contract Manufacturing Organizations (CMOs).Position SummaryThe Senior Pharmaceutical Quality...
-
Indianapolis, Indiana, United States Lantheus Medical Imaging Inc Full timeJob OverviewLantheus Medical Imaging Inc. is a leader in the medical imaging field, committed to enhancing patient care through innovative diagnostics and therapeutics. With a strong presence in the industry for over six decades, we are dedicated to fostering a collaborative and inclusive environment.Position SummaryThe Senior Pharmaceutical Quality Engineer...
-
Senior Automation Engineer
5 days ago
Indianapolis, Indiana, United States Novartis Full timeJob DescriptionJob Summary:The Senior Automation Engineer will be responsible for managing and maintaining automation systems across the facility, ensuring compliance with internal GMPs, CSV, and external regulatory requirements.Key Responsibilities:Manage automation systems, including building management systems, room monitoring systems, process and...
-
Pharmaceutical Design Engineer
5 days ago
Indianapolis, Indiana, United States Kodiak Labor Solutions Full timeJob Description**About the Role**Kodiak Labor Solutions is seeking a skilled Pharmaceutical Design Engineer to join our team. As a key member of our design team, you will be responsible for designing and developing cleanrooms, hot cells, and other controlled environments for pharmaceutical construction projects.Key Responsibilities:Design and Drafting:...
-
Senior Process Engineer in Chemistry
2 weeks ago
Indianapolis, Indiana, United States Catalyst Life Sciences Full timeCatalyst Life Sciences is seeking a Senior Chemical Engineer to join our dynamic team. This role is integral to our operations within the pharmaceutical sector.Key Qualifications:PhD in Chemical Engineering is mandatory.Demonstrated experience in the pharmaceutical industry is essential.Expertise in small molecule development is required.As a Senior Chemical...
-
Pharmaceutical Environmental Quality Specialist
2 weeks ago
Indianapolis, Indiana, United States Eurofins USA PSS Insourcing Solutions Full timePosition OverviewAs a Pharmaceutical Environmental Quality Specialist, you will be responsible for the collection of Environmental Monitoring (EM) and utility samples at various client locations, adhering to established sampling protocols and documentation.Key Responsibilities:Conduct sampling and testing in compliance with industry standards.Be prepared for...
-
Senior Quality Assurance Supply Chain Associate
3 weeks ago
Indianapolis, United States Merck Group Full timeThis position supports the quality assurance processes within the QA Supply Chain department with a focus on transforming the way we work through continual improvement, ownership of transformative CAPAs and projects. The Senior Quality Assurance Supply Chain Associate will be responsible for improving site compliance, deploying risk-based oversight, and...
-
Senior Quality Assurance Supply Chain Associate
2 weeks ago
Indianapolis, United States Merck Group Full timeThis position supports the quality assurance processes within the QA Supply Chain department with a focus on transforming the way we work through continual improvement, ownership of transformative CAPAs and projects. The Senior Quality Assurance Supply Chain Associate will be responsible for improving site compliance, deploying risk-based oversight, and...
-
Senior Quality Assurance Supply Chain Specialist
2 weeks ago
Indianapolis, Indiana, United States Merck KGaA Full timeAbout the RoleThis position supports the quality assurance processes within the QA Supply Chain department with a focus on transforming the way we work through continual improvement, ownership of transformative CAPAs and projects. The Senior Quality Assurance Supply Chain Associate will be responsible for improving site compliance, deploying risk-based...
-
Senior Director-Global Quality Systems-Quality
2 months ago
Indianapolis, Indiana, United States Eli Lilly and Company Full timeAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...
-
Senior Director-Global Quality Systems-Quality
2 months ago
Indianapolis, United States Eli Lilly and Company Full timeAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...
-
Indianapolis, Indiana, United States Stratosphere Quality Full timeJob DescriptionPosition OverviewPlastics Quality EngineerSeeking a professional with extensive expertise in Injection Molding.Position Details:Compensation: $50 - $70 per hour (1099)Work Schedule: 1st shiftContract Duration: 3-6 weeksKey Responsibilities:Identifying and resolving issuesEnhancing processes – assessing and refining operations related to...
-
Indianapolis, Indiana, United States Merck KGaA Full timeAbout the RoleThis position supports the quality assurance processes within the QA Supply Chain department with a focus on transforming the way we work through continual improvement, ownership of transformative CAPAs and projects. The Senior Quality Assurance Supply Chain Associate will be responsible for improving site compliance, deploying risk-based...
-
Lead Quality Assurance Engineer
1 week ago
Indianapolis, Indiana, United States RBW Consulting Full timePrincipal Quality EngineerAs a prominent player in the Contract Development and Manufacturing Organization (CDMO) sector, RBW Consulting is seeking a seasoned Principal Quality Engineer. This role is pivotal in overseeing Equipment and Facility design, Commissioning, Qualification, and Procedural Development for extensive building initiatives.Supported by a...
-
Lead Quality Assurance Engineer
1 week ago
Indianapolis, Indiana, United States RBW Consulting Full timePrincipal Quality Engineer OpportunityAs a leading partner in the Contract Development and Manufacturing Organization (CDMO) sector, RBW Consulting is seeking a seasoned Principal Quality Engineer. This role is pivotal in overseeing Equipment and Facility design, as well as the Commissioning, Qualification, and Procedural Development associated with...
-
Lead Quality Assurance Engineer
2 weeks ago
Indianapolis, Indiana, United States RBW Consulting Full timePrincipal Quality EngineerAs a key player in a rapidly expanding Contract Development and Manufacturing Organization (CDMO), we are seeking a seasoned Principal Quality Engineer. This individual will serve as the primary liaison for the design, commissioning, qualification, and procedural development of equipment and facilities for large-scale construction...
-
Chemical Engineering Expert
2 weeks ago
Indianapolis, Indiana, United States Catalyst Life Sciences Full timeCatalyst Life Sciences is seeking a Senior Chemical Engineer to join our dynamic team. In this role, you will contribute to innovative projects within a leading pharmaceutical organization.Key Qualifications:PhD in Chemical Engineering is mandatory.Demonstrated experience in the pharmaceutical sector.Expertise in small molecule development is essential.This...
