QA Engineer

766 million lives were touched by Novartis medicines in 2021, and while we're proud of this, we know there is so much more we could do to help improve and extend people's lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do here at Novartis!

The Quality Assurance Engineer is responsible for the design, construction, validation, maintenance and overall compliance of facilities, systems, and processes at the AAA Indianapolis radioligand manufacturing site.

Your responsibilities include, but are not limited to:

• Quality and Compliance aspects of design working in collaboration with Engineering, technical functions, Manufacturing Operations and outside consultants and contractors to ensure that new facility is:

o Compliant with all appropriate Novartis QMS and regulations (e.g. FDA, EMEA and other major health authorities) for GMP manufacturing

o Capable of manufacturing products that are safe, effective and that meet all applied controls and specifications.

o Capable of meeting intended design goals of output volume, turnaround time and operating and product costs.

• Provide strategic quality input on the translation of commercial product requirements into technical solutions that are capable of meeting defined CQAs (product Critical Quality Attributes) and CPPs (Critical Process Parameters).
• Contribute to the definition of project plan, control requirements and processes to deliver the new manufacturing facility on time, to required quality and compliance standards and within budget.
• Contribute to design of facility, utilities and process equipment from a Quality and Compliance perspective.
• Act as Quality approver on project deliverables, as defined in the project plan.
• Work with validation colleagues to define the initial asset life-cycle model and qualification and validation strategy, to ensure successful validation of the facility. Play a lead role in the planning, execution and closure of commissioning, qualification and validation activities from a Quality functional perspective.
• Collaborate with MS&T to ensure products are maintained in a validated stated.
• Author and/or approve Standard Operating Procedures in support of project activity and deliverables.
• Acts as the Quality approver of change controls, deviations, and CAPAs required to maintain the manufacturing facility in a GMP state.
• Works with supplier and Vendor Management colleagues to ensure that suppliers of goods and services for the new manufacturing facility are compliant and capable of fulfilling their contracted requirements.
• Perform QA approval of major and critical investigations.
• Lead and support internal self-inspections.

The pay range for this position at commencement of employment is expected to be between $88,000.00 and $132,000.00 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. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

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Diversity & Inclusion / EEO

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. 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 and empowers our people to unleash their full potential.

Minimum Requirements

What you'll bring to the role:

Bachelor's degree preferably in engineering, chemistry or biochemistry.

• 5 years of experience in a GxP pharmaceutical manufacturing operations
• 2 years of experience in a quality assurance role
• Strong knowledge and experience with the application of CFRs and cGMPs and have been involved in regulatory inspections.
• Experience with comprehensive audit support of all internal and external audits in support of the product manufacture and launch.
• Experience with radiopharmaceuticals is a plus.
• Comprehensive knowledge of FDA and EU regulations and experience in US and international regulatory agency inspections.
• Direct experience with commissioning, qualification and validation to meet FDA and other health authority requirements.
• Direct experience reviewing and/or authoring standard operating procedures and partnering with operations on product related investigations and deviations.
• Excellent oral and written communication skills with strong technical writing experience required.
• Experience participating in internal audits, identify findings, driving to resolution and providing closure report is desired.
• Ability to synthesize data and summarize outcomes to provide recommendations on a compliant path forward.
• Why Advanced Accelerator Applications (AAA)?

Thousands of people die of cancer around the world every day. At Advanced Accelerator Applications (AAA), a Novartis company, our mission is to transform lives through radioligand therapy in nuclear medicine to fight several leading types of cancer. How will we continue to be on the cutting edge of medicine? We believe new groundbreaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis!

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 and empowers our people to unleash their full potential.

Accessibility and Reasonable Accommodations:

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] call 1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network.

Division

ONCOLOGY

Business Unit

ADVANCED ACCELERATOR APPLICATIONS

Location

USA

Site

Indianapolis, IN

Company / Legal Entity

AAA USA Inc.

Functional Area

Quality

Job Type

Full Time

Employment Type

Regular

Shift Work

No