Quality Engineer (Manufacturing)

Novartis; Indianapolis (IN); On-site; USD 60,000 - 80,000; Full time

Job summary

Join a leading global medicines company as a Quality Engineer in Indianapolis. You will support QA operations for the new Radioligand Therapy manufacturing site, ensuring compliance with quality standards and regulatory requirements. This temporary contractor role offers competitive pay and a chance to impact patient lives through innovative therapies.

Benefits

Health Insurance

Dental Insurance

Vision Insurance

401k

Qualifications

• 2+ years in GxP biopharmaceutical manufacturing operations.
• 1+ year in a quality assurance role.

Responsibilities

• Act as QA contact point for design and validation activities.
• Collaborate with MS&T department for project qualification.
• Support regulatory submissions and inspections.

Skills

Collaboration

Communication

Process Improvement

Education

Bachelor's Degree in Life Sciences

Bachelor's Degree in Chemistry

Job description

Join to apply for the Quality Engineer (Manufacturing) role at Novartis.

This range is provided by Novartis. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$37.16/hr - $37.16/hr

:::Please note: This is a temporary contractor opportunity at Novartis :::

Novartis touches the lives of a tenth of the world’s population. Every role here, regardless of contract type, makes an impact on human life!

Novartis US partners with external managed service provider Magnit Global to offer engaging temporary contractor opportunities like this, to those who are looking for flexibility in their career while gaining new skills and experiences providing services to an inclusive global medicines company. Click here to learn more about Magnit www.magnitglobal.com

Ready to work with/through Magnit at Novartis? Please read on...

Quality Engineer

At Advanced Accelerator Applications, a Novartis company, we are committed to leading innovation in nuclear medicine and delivering the next generation of targeted radioligand therapy to cancer patients. We are looking for an experienced Quality Engineer with previous experience in a GMP pharmaceutical manufacturing environment to help us reach our ambitious goals.

As the Quality Engineer, you will be responsible for providing support to the QA Operations organization for the review and approval of technical records. Your focus will be to support the design, construction, commissioning, qualification, and validation of the new Radioligand Therapy (RLT) Isotope Manufacturing site in Indianapolis, ensuring compliance with quality objectives and regulatory requirements.

Key Responsibilities:

• Act as QA contact point and subject matter expert for the design, construction, commissioning, qualification, and validation activities for manufacturing and QC areas.
• Collaborate with the Site’s Manufacturing Science and Technology (MS&T) department to review and approve the establishment, review, and approval of the expansion project qualification and validation master plans.
• Support the creation and review of source documentation used for regulatory submissions. Assist in the preparation and execution of pre-approval inspections by FDA or other health authorities.
• Under the guidance of the Quality Assurance Engineer Lead, perform triaging and initiation of events (Deviation, Action, CAPA, etc.), working with cross-functional departments during triaging.
• Support QA Operations as a valued business partner, fostering a culture of safety, quality, delivery to patients, cost efficiency, compliance, and data integrity.
• Engage actively in process improvement initiatives and ensure adherence to regulations and Novartis quality standards.
• Write and review Standard Operating Procedures (SOPs) as needed.
• Perform other related duties as assigned.

Essential Requirements:

• Bachelor's Degree, preferably in Life Sciences, Chemistry, or a related field. Alternatively, 3-5 years of pharma industry experience including quality assurance roles.
• At least 2 years of experience in GxP biopharmaceutical manufacturing operations.
• At least 1 year of experience in a quality assurance role.
• Open and clear collaboration and communication skills.
• QA and QC experience in biotech pharmaceutical industry, with environmental monitoring and cleanliness zones preferred.
• Proven track record with cGMP requirements.
• Knowledge of FDA regulations and experience with US regulatory inspections.

Location: Indianapolis, IN (Onsite)

Pay Rate: $29.77 - $37.16/hour based on experience and qualifications (W2 only)

Contract Duration: 12 months

Benefits: Health, dental, vision, 401k

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of passionate people. Collaborate, support, and inspire each other to achieve breakthroughs that change lives. Ready to create a brighter future together?

EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate based on race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or other protected statuses.

Accommodation: If you require reasonable accommodation, please contact Magnit at [e-mail].