Senior Equipment Specialist for API
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Hillerød
Are you energised by using this knowledge to guide and mentor others to succeed? Do you thrive on solving complex equipment tasks such as optimisation, validation, and project planning of new facility initiatives? Would you like to be part of a highly skilled production unit dedicated to make a difference for people living with haemophilia? If yes, you could be our new Senior Equipment Specialist. Apply today and join us for a life-changing career!
The position
As Senior Equipment Specialist for API (Active Pharmaceutical Ingredient) you will be overall responsible for ensuring that our equipment and environment complies with GMP and ISO regulations as well as ensuring and managing optimisation of production equipment performance. Your main responsibilities will be focused on:
• Setting the direction to ensure a risk-based approach to validation and maintaining the validated state of the equipment (incl. calibration and maintenance strategy approach)
• Providing technical instruction and supervision of process engineers and technicians
• Be part of the facility department management group and reporting to the Department manager as well as working closely with specialists and other stakeholders such as equipment, maintenance, and environment
• Participating in inspections and audits by bringing in your expert knowledge Qualifications
To be a competitive candidate, you should have:
• A master’s degree in Life Science or Engineering
• Extensive and technical experience within the pharma industry and general experience with production and/or development of pharmaceutical products – preferably with API
• Proven track record of validation/qualification experience in GMP manufacturing or CMC (Chemistry, Manufacturing and Controls) process development in the pharmaceutical, biotechnology or similar industry
• Extensive experience in systematic problem solving and the lean toolbox
• Professional proficiency in English On a personal level, you feel empowered by guiding and mentoring employees and making them succeed. You have role model behaviour and feel comfortable giving and receiving feedback in an open and respectful way that fosters personal growth. It is important to have strong analytical skills combined with an in-depth business knowledge, too. About the department
You will be part of a dynamic business area under Biotech and Rare Disease API Denmark, which produce Active Pharmaceutical Ingredients (API) for Haemophilia patients across the world. Our production unit consists of three departments: Facilities, Production and New Product Entry. You will be reporting to the department manager of the Facilities department and will be working closely with specialists and other stakeholders in our own and the two other departments. The Facilities department consists of six teams: Equipment, Maintenance, Cleaning, Facility Support and Environment 1. Line and 2. Line. You will all be supporting and is responsible for maintaining existing production equipment and implementing new equipment in the facility. Working at
Biotech & Rare Disease (BRD) is part of Product Supply, which is a global production network at the forefront of technology and quality production of pharmaceutical products. In BRD, we are not only supplying all products to people living with serious chronic diseases, but we also use our competences in biotech to support the growing efforts into completely new production platforms and therapy areas for . We are more than 3000 dedicated colleagues working at six production sites in Denmark and the United States. Here we cover the entire production value chain where raw materials are cultivated, purified, formulated, filled, assembled in devices, packed, and distributed across the globe. As more and more people need our products, we support 's initiatives in new therapy areas. Every day, we work to streamline and expand our capacity through process innovation, automation, and the introduction of new technology. Contact
For further information, please contact Senior Manager of Facilities, Sabine Blicher Lerche Kruse at +.
Deadline
31 May 2024. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
The position
As Senior Equipment Specialist for API (Active Pharmaceutical Ingredient) you will be overall responsible for ensuring that our equipment and environment complies with GMP and ISO regulations as well as ensuring and managing optimisation of production equipment performance. Your main responsibilities will be focused on:
• Setting the direction to ensure a risk-based approach to validation and maintaining the validated state of the equipment (incl. calibration and maintenance strategy approach)
• Providing technical instruction and supervision of process engineers and technicians
• Be part of the facility department management group and reporting to the Department manager as well as working closely with specialists and other stakeholders such as equipment, maintenance, and environment
• Participating in inspections and audits by bringing in your expert knowledge Qualifications
To be a competitive candidate, you should have:
• A master’s degree in Life Science or Engineering
• Extensive and technical experience within the pharma industry and general experience with production and/or development of pharmaceutical products – preferably with API
• Proven track record of validation/qualification experience in GMP manufacturing or CMC (Chemistry, Manufacturing and Controls) process development in the pharmaceutical, biotechnology or similar industry
• Extensive experience in systematic problem solving and the lean toolbox
• Professional proficiency in English On a personal level, you feel empowered by guiding and mentoring employees and making them succeed. You have role model behaviour and feel comfortable giving and receiving feedback in an open and respectful way that fosters personal growth. It is important to have strong analytical skills combined with an in-depth business knowledge, too. About the department
You will be part of a dynamic business area under Biotech and Rare Disease API Denmark, which produce Active Pharmaceutical Ingredients (API) for Haemophilia patients across the world. Our production unit consists of three departments: Facilities, Production and New Product Entry. You will be reporting to the department manager of the Facilities department and will be working closely with specialists and other stakeholders in our own and the two other departments. The Facilities department consists of six teams: Equipment, Maintenance, Cleaning, Facility Support and Environment 1. Line and 2. Line. You will all be supporting and is responsible for maintaining existing production equipment and implementing new equipment in the facility. Working at
Biotech & Rare Disease (BRD) is part of Product Supply, which is a global production network at the forefront of technology and quality production of pharmaceutical products. In BRD, we are not only supplying all products to people living with serious chronic diseases, but we also use our competences in biotech to support the growing efforts into completely new production platforms and therapy areas for . We are more than 3000 dedicated colleagues working at six production sites in Denmark and the United States. Here we cover the entire production value chain where raw materials are cultivated, purified, formulated, filled, assembled in devices, packed, and distributed across the globe. As more and more people need our products, we support 's initiatives in new therapy areas. Every day, we work to streamline and expand our capacity through process innovation, automation, and the introduction of new technology. Contact
For further information, please contact Senior Manager of Facilities, Sabine Blicher Lerche Kruse at +.
Deadline
31 May 2024. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Hillerød.
Jobbet er oprettet på vores service den 7.5.2024, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- 27.05.2024
- Øvrige
- Hillerød
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