May 02, 2022

Job Description

Compliance Manager Engineering (f/m/d), Novartis Technical Operations, Kundl, Austria

160 Million! This is the number of antibiotics packs that we produce in Kundl and deliver to patients in more than 80 countries all over the world in a year! Your role will be to support commissioning & qualification relevant engineering projects, coordinates and standardizes technical GMP compliance topics and supports the implementation of major technical GMP compliance initiatives as well as ensuring the technical GMP compliance.

Your key responsibilities:

Your responsibilities include, but are not limited to:
• Strategy & Organizational Development
• Continuous improvement of technical processes and standards Support of Deviations and Corrective and Preventive Actions (CAPAs) within area of responsibility
• Share best practices and lessons learnt with all sites and global networks
• Participation in different technical GMP compliance expert and study groups
• Mutual representation of “C&Q Engineers” in case of holidays, external trainings and meetings, etc.
• Evaluation of education and training requirements including organization and performance of trainings
• Harmonization/ Standardization
• Ensure technical GMP compliance with national regulations, Novartis guidelines, procedures and standards
• Review of global procedures and standards
• Implementation of global procedures and standards
• Development, preparation and maintenance of technical GMP compliance standards and SOPs
• Coordination, harmonization and standardization of technical GMP compliance activities, systems, tools and compliance standards e.g. CFR, EU GMP Guide, WHO, ICH and ISPE
• Rollout and implementation of technical initiatives and projects
• Support, monitoring, reporting and auditing of site-implementation OPEX Projects / Initiatives
• Act as contact person regarding technical GMP compliance questions within engineering and interface to Campus and site QA-departments as well as the Site Compliance engineers Side Support and Consolidation:
• Support of audits and inspections reviews including follow-up measures performed by authorities, Novartis Global Compliance Auditing and external customer
• Performance of engineering compliance checks, preparation of the corresponding reports as well as follow-up regarding timely closure of
• CAPAs to observations
• Networking & Communication
• Support of contractor management activities within Campus Engineering KU/SC

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:
• 1-2 years (University degree) / 3-4 years (HTL) of work experience required
• Analytical abilities and problem-solving skills
• Excellent communication, presentation and organizational skills, open communication
• Collaborating across boundaries
• Functional Breadth People Challenges
• Project Management

Desirable requirements:
• Full Proficiency in English and German
• University degree in engineering (Dipl. Ing. / M. Sc. / B. Sc.) or equivalent; Higher technical Education (HTL)
• Additional experience as plant engineer, automation engineer, QA engineering (desirable

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!

In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development options as well as worldwide career opportunities within the Novartis group. In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is € 52.204/year (on a full time basis). The actual salary will be significantly higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies
We are open for part-time and job sharing models and support flexible and remote working where possible.

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.
Our recruitment decisions are based on selecting the best person for the job, regardless of gender, religion, age, colour, race, sexual orientation, nationality or disability.

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
Novartis Technical Operations
Technical Operations
Full Time
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Compliance Manager Engineering (f/m/d)

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