Job ID
358464BR
Nov 21, 2022
India

With 64 manufacturing sites in 26 countries, our aspiration is to become the top manufacturer of innovative and generic medicines in the industry.

Position Purpose:
The C&Q Engineer will be responsible for on-site C&Q activities in line with GDP, GEP & CGMP principles
Incumbent will drive a team of Validation/Verification, Commissioning Engineers/ subject matter experts to perform the commissioning/qualification of equipment, utility systems, facilities and automation systems, CSV System for OSD site.

Your key responsibilities:
Your responsibilities include, but are not limited to:

• Planning, developing, execution, reporting of C&Q deliverables for project. Liaison with the Design Lead (Architect Engineer), Project manager, other stakeholders to enable effective leveraging (where applicable) and timely Right First Time execution and compliance of Commissioning & Qualification deliverables.
• Develop moderate to highly complex protocols for validation projects using a risk based approach that meets regulatory requirements and industry practices. Develop FAT, IQ, OQ, PQ Summary Reports, SOPs, Engineering Change Requests, etc. Review and Approval of Protocols, Reports and associated Deviations as applicable.
• Provide oversight and assign work and provide resolution to a wide range of problems on a day to day basis. Management of Contractors, scheduling, resources, budget. Trending of data, issuance of reports in a timely & accurate manner to support Project metrics.
• Maintain Master plans & Inventory of systems. Generation, review and approval of C&Q strategies as applicable. Interfacing with Global/Local stakeholders to ensure compliance. Represents the Validation Methodology and outputs at Compliance Quality / Regulatory Inspections.
• Conducts training as required. Maintain change control system for projects. Ensure projects on site are developed through their various stages of scope, definition, approval and implementation.
• Any other responsibility that may be assigned time to time. Ensure sharing and leverage of best practices and expertise within the Novartis engineering community. Ensure implementation of technology strategy and the approved equipment standards and project execution standards.
  

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

What youll bring to the role:

• BE - Mechanical or Electrical with min 6+ years of handing various engineering projects in pharma industry & preferably OSD Mfg., Plant.
• Experience interacting with or creating material for representatives of regulatory agencies and executive level staff.
• Experience with investigations into manufacturing deviations and determination of product impact potential, root cause and corrective actions.
• Previous experience in leading Projects in Pharmaceutical, Biopharmaceutical and or Medical Device Industries, covering utilities, facility clean rooms, process equipment & automation systems
• Knowledge of Validation Lifecycle approach (Commissioning Protocols, etc) guidelines, international regulatory requirements and standards and other in.
• Hands on experience in Processes and Plant Maintenance.
• Knowledge of 21CFR part 11 compliance, preparing & reviewing CSV qualification document.

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

Join our Novartis Group 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

Why Sandoz?
500 million patients were touched by Sandoz generic and biosimilar medicines in 2021 and while were proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.

How will we do this? 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 worlds toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do here at Sandoz!
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Division
Novartis Technical Operations
Business Unit
NTO SANDOZ TECHOPS
Location
India
Site
Mumbai
Company / Legal Entity
Sdz Pvt Ind
Functional Area
Technical Operations
Job Type
Full Time
Employment Type
Regular
Shift Work
Yes