Senior Technical Manager for Aseptics
vor 1 Monat
Senior Technical Manager for Aseptics (d/f/m), STO FDF, Kundl, Austria
Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines. Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally. In this role you will be play a crucial part in the implementation for new aseptic powder and liquid filling lines (vials and syringes) and combination product equipment from design to successful commercial production of Antibiotics at FDF Kundl. Join us as a Founder of our ‘new’ Sandoz Your key responsibilities: Your responsibilities include, but are not limited to: • Define user requirements for new equipment in alignment with Annex 1, establish proper aseptic handling processes and manage the corresponding qualification and validation activities in accordance with project budget and timelines together with a cross functional team.• Act as Subject Matter Expert for new and established aseptic Fill & Finish processes including visual inspection and support of internal and external audits.
• Have an in-depth knowledge of aseptic manufacturing operations and process equipment to support Manufacturing, Quality, Automation and Validation
• Define and drive Opex initiatives to improve efficiency and output within the boundaries of aseptic manufacturing.
• Ensuring all the systems are in compliance with all Regulatory requirements
Diversity and Inclusion
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
What you’ll bring to the role:
Essential Requirements:
• A minimum of 5 years of experience within a Sterile Drug Product Manufacturing is essential.
• Detailed knowledge of Sterile Drug Product manufacturing with different aseptic filling techniques (vials, syringes) and systems (conventional, RABS, isolator) is a plus.
• Experience in design, qualification, validation and start-up of new aseptic filling lines including media fill concepts and associated equipment
• Experience in visual inspection procedures and methods of liquids
• Experience on the implementation of new primary packaging components and single use systems within Sterile Drug Product facilities.
• Knowledgeable on current industry practices and regulatory requirements within the Sterile Drug Product manufacturing area
• The candidate will have demonstrated proficiency communicating and collaborating at a variety of levels, coupled with excellent organization and planning skills.
• Problem solving and project management ability, as well as lean manufacturing experience is essential.
• Fluent English and fluent German. Desirable requirements:
• Experience with Technical Transfer of new processes is desirable. Why Sandoz? Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably. Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged The future is ours to shape Imagine what you could do here at Sandoz 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. 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 € 73.112,90 /year (on a full time basis). In most cases, the actual salary will be higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies. We are support flexible and remote working where possible. Join our Sandoz Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, join the Network here: Job search | Sandoz #Sandoz #J-18808-Ljbffr
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