~~~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 looking to gain 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...
Microbiology Expert
At the Indianapolis Isotopes site, we are seeking a highly qualified Microbiology Expert with strong skills in Environmental Monitoring, Process Qualification, and Method Validation. This position requires a blend of technical expertise, regulatory knowledge, and a strong ability to document and execute different microbiological processes. The successful candidate will play a key role in ensuring microbiological control systems are qualified and validated, and that all microbiological testing methods meet regulatory standards.
Key Responsibilities:
• Environmental Monitoring:
Lead and manage environmental monitoring (EM) programs in controlled environments (e.g., clean rooms, manufacturing facilities). Oversee microbial testing, environmental sampling, and the qualification of monitoring systems.
• Process Qualification & Validation:
Develop, implement, and execute qualification protocols for environmental monitoring systems, ensuring they meet GMP and regulatory requirements. Lead the qualification and validation of microbiological testing methods, including methods for bioburden, endotoxin, sterility, and microbial limits testing.
• Data Analysis & Reporting:
Analyze microbiological data from environmental monitoring, identifying trends, issues, and opportunities for continuous improvement. Prepare and present comprehensive reports to key stakeholders.
• Regulatory Compliance:
Ensure compliance with FDA, EMA, GMP, and other regulatory guidelines related to environmental monitoring and microbiological testing. Maintain up-to-date knowledge of applicable standards.
• Validation & Qualification Protocols:
Develop, validate, and implement environmental qualification and monitoring plans, ensuring that environmental control systems function as intended.
Key Skills & Qualifications:
Education:
Bachelor’s degree (or higher) in Microbiology, Biology, Environmental Science, or a related field.
Experience:
Minimum of 3 years of experience in microbiology, with a focus on environmental monitoring, qualification processes, or related fields in a regulated environment (pharmaceutical, biotechnology, medical devices, etc.).
Expertise in Environmental Monitoring:
In-depth knowledge of environmental monitoring best practices, qualification protocols, microbial testing techniques, and associated instrumentation.
Process Qualification:
Strong understanding of process qualification procedures, including IQ/OQ/PQ (Installation Qualification, Operational Qualification, Performance Qualification) protocols.
Regulatory Knowledge:
Familiarity with global regulatory requirements and standards (e.g., FDA, EMA, ICH, GMP) pertaining to environmental monitoring and microbiological control.
Location: Indianapolis, IN (Onsite)
Pay Rate: $25 - $30.14/hr based on experience and qualifications (W2 Only)
Contract: 12 months
Health, dental, vision, 401k
Why Novartis?
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 we can reinvent what's possible when we collaborate with courage to ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine the impact you could make here at Novartis!
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment with diverse teams representative of the patients and communities we serve.
To do our best work we need different viewpoints, which is why here at Magnit, we celebrate diversity and embrace inclusion. As an equal opportunity employer, Magnit is dedicated to building a team that represents a variety of backgrounds, perspectives, and skills. We strive to ensure that we maintain a positive and enriching work environment for all.
Accommodation:
If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to Magnit at directsourceproteam@prounlimited.com.
Commitment to Diversity and Inclusion / EEO
