347414BR
Jun 21, 2022
USA

Job Description

10. The number of dedicated and inspired professionals in the Engineering Services function who are empowered to ask new questions and make bold decisions to support bringing lifesaving medicines and treatments to patients. Come join our curious and unbossed team and make an impact on patient’s lives every day!
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You will ensure compliance to the regulatory requirements of the facilities, utilities, equipment and analytical instruments qualification processes, and activities performed in the Novartis, Morris Plains, NJ facility.

Recommend and implement improvements to the qualification process.

Perform a variety of routine and non-routine tasks related such as managing and coordinating qualification projects and changes: Prepare risk and impact assessments and other evaluations. Support Process Unit (PU), Manufacturing, Science and Technology (MS&T), Operations (OPS), Quality Control (QC) and Quality Assurance (QA) departments.

This includes the incumbent to:

1. Provides oversight to complex qualification activities and projects including the support of internal and external audits

2. Leads multifaceted qualification activities with limited oversight

3. Coordinates Qualification activities in compliance with corporate policy, local procedures, and regulatory expectations

4. Coordinates and develops with PU, MS&T, OPS, QC and QA Teams qualification projects and plans and identifies the “critical to quality” parameters impacting qualification activities

5. Prepares Qualification Master Plans, Risk and Impact Assessments, Protocols and Summary Reports and coordinates review and approvals of the documents

6. Authors/reviews/updates/assists in developing departmental standard operating procedures (SOPs) and qualification programs

7. Conducts field execution of Installation, Operational and Performance Qualification protocols

8. Ensures all activities follow cGMP, Health Authority regulations and Novartis Policies

9. Determines the Qualification requirements based on a worst-case matrix approach for the site and provides qualification solutions that meet regulatory requirements within budget, where applicable.





While Novartis does not require vaccination at this time, for certain Novartis sites in the US all associates and candidates may be required to either upload an image of their COVID-19 vaccine card demonstrating proof of full vaccination for COVID-19 (or other similar evidence of vaccination) or proof of a negative COVID-19 test taken by the associate or candidate within the past seven days to enter any of our sites and/or customer office or healthcare facility, as well as prior to participating in other work related off-site meetings. Employees working in customer-facing roles must adhere to and comply with customers’ (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to [email protected].

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:

Education:
• Bachelor's degree is required; subject area in Engineering is preferred


Experience:
• 5+ years of Pharmaceutical industry experience required

• 5+ years of Qualification experience, such as Facilities, Utilities, Equipment, and/or Analytical Instruments Qualification experience is required, per above description

• Good working knowledge of GMPs in pharmaceutical manufacturing facilities and major utilities

• Experience interacting with various organizational levels and fostering multi-functional and cross-cultural teamwork

• Knowledge of industry standards 21 CFR Part 11, Validation, and GAMP

• Experience working in controlled environments & classified areas requiring special gowning is a plus


Skills:
• Strong business communication skills

• Capable to work independently with minimal direction

• Self-directed and able to manage multiple priorities

• Adept at working well with others in a team environment

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Why Novartis?

766 million lives were touched by Novartis medicines in 2020, 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 tackle the world’s toughest medical challenges aggressively and ambitiously. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do here at Novartis!

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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 inclusion workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.
Novartis is an equal opportunities employer and welcomes applications from all suitably qualified persons.

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Join our Novartis Group 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

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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] or 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.
https://www.novartis.com/careers/careers-research/notice-all-applicants…
Novartis Technical Operations
NTO SITE DEVELOPMENT
USA
Morris Plains, NJ
Technical Operations
Full Time
Regular
No
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347414BR

Engineering and Validation Specialist (Morris Plains, NJ)

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