~~~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...
Qualification Engineer
Requirements
Education:
A bachelor's or master's degree in engineering, preferably in chemical or mechanical engineering, or a related field.
Experience:
5+ years of relevant experience in the pharmaceutical industry, with a focus on CQV activities. This experience should include hands-on experience in executing validation protocols, but is focused more on the development of these documents for equipment qualification, and commissioning activities.
Expertise in regulatory requirements: Strong knowledge and understanding of FDA regulations, GMP (Good Manufacturing Practices), and other relevant regulatory guidelines applicable to the pharmaceutical industry.
Validation and qualification experience: Extensive experience in developing and executing validation protocols, including equipment, facilities and utilities qualification.
Project management skills:
Ability to effectively manage and lead CQV projects, including developing project plans, coordinating with cross-functional teams, ensuring adherence to timelines, and delivering projects within budget.
Technical skills:
Proficiency in utilizing various CQV tools, methodologies, and techniques, such as risk assessments, validation master plans, validation protocols, and data analysis. Familiarity with computerized systems validation (CSV) and automated systems is a plus.
Leadership and communication:
Strong leadership skills, with the ability to effectively communicate and collaborate with cross-functional teams, stakeholders, and clients. Excellent oral and written communication skills are necessary for preparing reports, presenting validation findings, and training personnel.
Problem-solving and critical thinking:
Strong analytical and problem-solving skills to identify and resolve deviations in a timely manner and ensure compliance with regulatory requirements.
Quality mindset:
A strong commitment to quality and compliance, with an understanding of quality systems and continuous improvement concepts like Lean Six Sigma.
Location: Morris Plains, NJ (Onsite)
Pay Rate:$54.25-$72.08/hour based on qualifications and experience(W-2/only)
Contract: 13+ 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 directsourcing@magnitglobal.com.
Commitment to Diversity and Inclusion / EEO
