346725BR
Jun 14, 2022
Slovenia

Job Description

28,000 associates of more than 100 nationalities! Deliver high quality and affordable medicine on time, every time, safely and efficiently.

In GOC Engineering within C&Q team we are looking for a new Commissioning&Qualifications Engineer II.

Your key responsibilities:

• Defining and producing commissioning and qualification plans and qualification reports.
• Establishing and maintaining general procedures for commissioning and qualification and for the delivery of training.
• Conduct GMP risk assessments (including Sensor Risk Assessment - SRA).
• Providing technical support for the implementation of Performance Qualification (PQ) and Process Validation (PQ), and integrating and coordinating the activities of internal and external commissioning and qualification contractors in accordance with timelines, requirements and financial resources.
• Technical/engineering change management: defining, approving, implementing and closing changes, providing support to resolve and manage deviations on equipment and production information systems.
• Managing or participating in project implementation • preparing user requirements, estimating investment costs, coordinating with suppliers, scheduling, ensuring up-to-date documentation, participating in commissioning and qualification, preparing work instructions and user training.
• Ensuring a cost-effective C&Q process that is both compliant with current regulatory requirements in all areas (GMP, HSE, etc.) and ensuring improvements, best practices and periodic activities.

Diversity & Inclusion / EEO

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

Minimum Requirements

What you will bring to the role:
• University degree in a technical field (mechanical eng., automation, electrical eng., computer eng., IT or other similar sciences).
• Active knowledge of English and Slovenian. Knowledge of German is an advantage.
• Knowledge of commissioning approaches and qualification of GMP systems, GxP regulatory and pharmaceutical manufacturing equipment and systems.
• Experience in project management.
• Good communication skills, ability to work independently, make decisions and set priorities.
• Openness to learn new skills, proactive, independent, team player.

You’ll receive
Competitive salary, Annual bonus, Flexible working schedule, tailored to your needs, possibility to work from home, Pension scheme, Employee Recognition Scheme, Sports Club Membership, employment at Top SI Employer, Unlimited learning and development opportunities.


We offer permanent employment with 6 months of probation period.

You are kindly invited to submit your application in English language, including CV by 28th of June 2022.

Why Novartis?

More than 750 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 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!

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.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Join our Novartis 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
Novartis Technical Operations
NTO ENGINEERING
Slovenia
Ljubljana
Technical Operations
Full Time
Regular
No
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346725BR

C&Q Engineer II (m/f/d)

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