Jul 12, 2022

Job Description

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:
Provide leadership for Commissioning & Qualification activities and lead the customer interface activities for the various sites (large and small molecule) and to lead the Projects Facility, Process, HVAC, Clean room and Utility Services Commissioning & Qualifications activities including developing the Protocols and execution of reports for Pharmaceutical OSD/Injectable/API/Oncology/Biotechnology /Vaccine manufacturing facilities. Responsible for handling multiple projects Commissioning & Qualifications activities considering end to end Project management. Will also be responsible for organizing, budgeting, scheduling, completing & supervising the performance of project as per required timelines.

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

• Responsible for review/execution/compiling of Facility, Process, HVAC, Clean room and Utility Services Commissioning & Qualifications activities Protocols/reports for the Pharmaceutical facilities which includes OSD/Injectable/API/Oncology/Biotechnology /Vaccine manufacturing facilities. Responsible for onsite support C&Q activities by following ISPE/ASTM methodologies using GDP, GEP, C&Q Base line guides, GAMP 5 & cGMP Principles.

• Planning, developing, execution, reporting of C&Q Work. Coordination with different package design engineers & Clients, Project managers to enable effective demonstrating and timely Right First Time Documents preparations, execution and compliance of Commissioning & Qualification work. In depth knowledge of Regulatory Guidelines- USFDA, MHRA, WHO, ISO, 21 CFR part 11 & other regulatory guidelines

• Preparations of Commissioning & Qualifications Protocols/ Standard operating Procedures/ Work instructions as applicable. Review of Validation master plan, Validation plans, Validation Documents, Commissioning & Validation execution of Clean Room & HVAC Systems (Such as DQ, IQ, OQ & PQ) in Pharmaceutical Industries as per the required standards. Preparation and review of qualification protocols, Temperature mapping protocols, Layouts and SOPs as per established procedures.

• Preparations & execution of Pre-commissioning & Commissioning checklists for various systems including Facility & Process/Utility Equipment. Preparation & execution of Facility, Utility & process equipment FAT/SAT Protocols/Reports. Must having the experiences and understanding of cleanroom facility and requirements. Must have knowledge of computer system validation requirement and preparation and execution of protocol related to computerized system with relevant partners.

• Complete / supervise with the help of contractors on daily basis for follow up and completion of Qualification, Re-qualification, thermal mapping, other engineering cGMP documentation activities and projects. Complete / supervise the Project/ engineering department online documentation all time with respect to Equipment, Qualification / Re-Qualification / Thermal Mapping/ Training / Re-Evaluation. Acts as authorized designate for the Manager and/or supervisor(s) to approve commissioning documents, SATs, FATs, qualification protocols and reports, and Change Controls within QMS TrackWise

• Participate in finalizing Concept, Basic and Detailed Engineering concepts (Mechanical/ HVAC/ Modular Panel/ Utility/ Process equipment & other subject areas, as applicable).Prepare/Develop Risk assessment documents at Various Project life cycle stages. Ensure Installation/ Execution of MEP package services inline to GMP, GEP, ISPE & other applicable standards as applicable. Supervise the progress of the C&Q activities on a regular basis and hold regular status meetings with all the sub-teams. Maintain strict alignment to the budgetary guidelines, quality and safety standards.

• Following & documenting the Project Change control management as per the agreed procedures. Ensure project documents are complete. Periodic Quality inspection of construction/Installation site activities as applicable. Ensure compliance to all statutory requirements. Since the C&Q Engineer is unlikely to handle only one project at a particular time, they should have the ability to multi-task. He should see to it that all the assigned projects under his supervision are going on smoothly. Works as a member of a team to achieve all outcomes. Performs all work in accordance with all established regulatory and compliance and safety requirements.

• Identify bottlenecks activities and overcome them for smooth project C&Q activities. Track and implement the changes while not compromising project C&Q timelines. Analyze, manage and mitigate risks ahead to prevent problems, delays etc. Strong collaborator orientation and must have prior experience of being functional representative for the defined group. Will be responsible for handling internal partners like User/QA group and external collaborators like Design consultant/Vendors.

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 you’ll bring to the role:
• Degree in engineering or equivalent with 15 plus years of experience in Pharmaceutical/ Chemical/ FMCG Industry.
• Deep understanding of Project Commissioning & Qualification activities like Facility/HVAC/Clean room / Black & Clean Utility services/Process equipment within pharmaceutical OSD/Injectable/API/Oncology/Biotechnology
• Leadership experience for the management of internal and external resources
• Sound knowledge in all aspects (cost, schedule, quality) of project controlling and reporting with special focus on trend analysis and forecasting
• Solid analytical / data interpretation skills
• Sound digital literacy (MS office, Track wise, MS project, SAP, PM-Tools).

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/networkProven resilience and strong leadership skills to drive change

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 here at Novartis!
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Novartis Technical Operations
Hyderabad, AP
Technical Operations
Full Time
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Commissioning & Qualification Team Lead

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