May 26, 2022

Job Description

Millions! Novartis made a decision to pursue early discovery research internally to allow us to quickly translate the most impactful discoveries into therapeutics for millions of patients.

The Lab Support Specialist - Validation will be responsible for maintaining, updating and troubleshooting all Laboratory Computerized System related issues. The Specialist will be responsible for performing Periodic Reviews, User Access Reviews, ERES Assessments of computerized systems and administration duties for locked stand-alone systems, In addition, the Specialist will assist with projects such as system upgrades and/or enhancements and Change Control Assessments/Evaluations. The Lab Support Specialist – Validation will serve as primary and/or secondary Laboratory System Administration of computerized systems.

Major Accountabilities
For all systems utilized by the laboratory, the Job can include all or some of the roles described below:
• Perform validation/qualification for Laboratory Category A, B and C systems by creating/ reviewing/executing validation documents including Validation Plan/Report, Functional Risk Assessments, User Requirements Specification, Functional/Design/Configuration Specification, IQ/OQ/PQ Test scripts, Supplier Assessments, and other requirements. Create/revise end user documents such as SOPs, Work Instructions, Forms, Handbooks
• Design and/or configure computerized systems to ensure compliance with 21 CFR Part 11 requirements (ERES and data integrity).
• Perform decommissioning/retirement of laboratory equipment and/or outdated systems/equipment.
• Provide oversight and project management for qualification/validation projects by creating timelines, organizing status update meetings, ensuring adherence to timelines, resolving roadblocks and communicating and/or escalating problems as needed.
• Support/perform Periodic Reviews/Assessments of laboratory systems/equipment.
• Train to serve as a primary or secondary System Administrator for Computerized and stand-alone laboratory equipment. Maintains inventory of laboratory instruments (equipment/systems).
• Assist with investigations and errors pertaining to laboratory system issues; complete assigned corrective and preventative actions (CAPA) in a timely manner
• Conducts self in a manner consistent with Novartis Behaviors and supports Quality Culture initiatives
• Adheres to all applicable procedures, cGMP’s, company policies, and all other quality or regulatory requirements (OSHA, DEA, FDA, HS&E, and USP/NF etc.)
• Ensures all work is performed in a safe, effective manner, and in compliance with the appropriate industry and regulatory standards, and Departmental, Plant, and Corporate quality and Behavioral Based Safety (BBS) goals.
• To support process experts in evaluation, planning and execution for main and sub processes (e.g. CAR, capacity planning, resources, etc.)
• Driven to learn new tasks, collaborate with other departments, and is a team-player

Note: This position may require the labeling, packaging or movement of hazardous (flammable, corrosive, toxic, etc.) waste within the facility.
In lieu of HAZWOPER training, the employee will receive training on the requirements of the Resource Conservation and Recovery Act pursuant to 40 CFR 265.16.

All employees that have received the above-mentioned training upon hire will receive annual refresher training that covers the OSHA HAZWOPER standard and the requirements of RCRA
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

• BA or higher in a scientific or related field

• Minimum 3 years pharmaceutical, chemical or related industrial experience preferred
• Previous experience with qualification/validation and/or maintenance of laboratory software is required

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 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 at Novartis!

Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

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

Accessibility and reasonable accommodation
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.

Novartis Technical Operations
Melville, NY
Information Technology
Full Time
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Lab Support Specialist - Validation

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