Validation Specialist
2 weeks ago
Copenhagen
We are looking for an experienced Validation Engineer who will play a crucial role in ensuring the validation of production equipment, adherence to modern product documentation practices, and conducting comprehensive risk assessments. The ideal candidate will bring expertise in the Pharma and Medical Device industry and possess a strong background in production validation processes.
Responsibilities:
As a Validation Engineer, you will play a pivotal role in the development, documentation, and approval of medical devices. Your main responsibilities will include:
- Develop and execute validation protocols for production equipment, ensuring compliance with industry regulations and standards.
- Collaborate with cross-functional teams to integrate validation activities seamlessly into the production process.
- Conduct equipment qualification and validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Work closely with the engineering and documentation teams to ensure the creation and maintenance of up-to-date and comprehensive product documentation.
- Implement and improve documentation processes to align with modern industry standards and best practices.
- Review and approve documentation related to production processes, ensuring accuracy and compliance.
- Conduct risk assessments for production processes, identifying potential hazards and developing mitigation strategies.
- Collaborate with cross-functional teams to implement risk management processes throughout the product lifecycle.
- Regularly review and update risk assessments to ensure continuous improvement and compliance.
Qualifications:
- Minimum of 3 years of relevant experience in medical devices and product approvals.
- Experience as a consultant within the field is a strong advantage.
- Proven experience in production validation within the Pharma and Medical Device industry.
- Strong experience with process- and equipment validation.
- Familiarity with regulatory requirements and standards (e.g., FDA, ISO).
- Strong understanding of risk assessment methodologies.
- Excellent communication and collaboration skills.
Personal Attributes:
- Systematic approach to work with attention to detail.
- Strong analytical thinking and problem-solving skills.
- Self-driven and proactive, with the ability to work both independently and as part of a team.
- Excellent communication and collaboration abilities.
- Capacity to manage tight deadlines and work in a dynamic environment.
- A nice person and colleague who values a solid work environment.
What We Offer:
We offer an exciting position in a continuously evolving company. You will become part of a dedicated team of experts and have the opportunity to influence and shape the processes surrounding product development and approval. Professional development and further education opportunities will be available.
Contact
If you want to hear more about this opportunity and the company, or if you have any questions regarding the position, please do not hesitate to contact us. If you wish to apply for the position, please send an updated version of your CV, together with what questions you might have, and we will get in touch with you soon.
JEPPE GOSVIG
Consultant
Talent engagement
-
Engagement Specialist
4 days ago
København Ø, Copenhagen, Denmark Flying Tiger Copenhagen Full timeDo you want to work with organic social media and influencer marketing in a global organization?Excited to take charge in creating engagement friendly and viral worthy content for Flying Tiger Copenhagen's TikTok community?Then we have the perfect opportunity where you can combine your creative expertise with your structural vision. We are looking for an...
-
Validation Specialist
2 weeks ago
København Ø, Denmark Black Swans Exist ApS Full timeCopenhagen We are looking for an experienced Validation Engineer who will play a crucial role in ensuring the validation of production equipment, adherence to modern product documentation practices, and conducting comprehensive risk assessments. The ideal candidate will bring expertise in the Pharma and Medical Device industry and possess a strong background...
-
Validation Engineer
7 days ago
København, Denmark Nomeco AS Full timeEr du passioneret omkring procesoptimering og validering? Så kan du får en nøglerolle i at sikre den validerede tilstand af vores faciliteter og udstyr i Nomeco! Nomeco er den foretrukne lægemiddelgrossist for apoteker og hospitaler i Danmark– ligesom vi er lægemiddelindustriens foretrukne strategiske logistikpartner. Vi er specialister i...
-
Engagement Specialist
5 days ago
København Ø, Denmark Flying Tiger Copenhagen Part timeDo you want to work with organic social media and influencer marketing in a global organization?Excited to take charge in creating engagement friendly and viral worthy content for Flying Tiger Copenhagen’s TikTok community?Then we have the perfect opportunity where you can combine your creative expertise with your structural vision. We are looking for an...
-
Clinical Specialist
1 month ago
København, Denmark United Light & Sound Rental ApS Full timeClinical Specialist The Clinical Specialist is an expert on Masimo Products & solutions and has excellent skills of educating users & maintaining customer relationships with a variety of clinicians and other key stakeholders. Duties & Responsibilities: • Acquire the knowledge and become an expert of Masimo Technology and Products. • Ability to...
-
Clinical Specialist
4 hours ago
København, Denmark United Light & Sound Rental ApS Full timeClinical Specialist, Denmark The Clinical Specialist is an expert on Masimo Products & solutions and has excellent skills of educating users & maintaining customer relationships with a variety of clinicians and other key stakeholders. Duties & Responsibilities: • Acquire the knowledge and become an expert of Masimo Technology and Products. •...
-
ERTMS Operation Specialist
4 weeks ago
København, Denmark Banedanmark Full timeWe are looking for a part time Operation Specialist as part of our Engineering team in the Fjernbane project – the project responsible for the introduction of a new signalling system based on ERTMS technology in Denmark. The Danish Signalling Programme, as the largest of its kind in Europe, is fully engaged replacing the old signalling system on the...
-
ERTMS Operation Specialist
4 weeks ago
København, Denmark Banedanmark Full timeWe are looking for a part time Operation Specialist as part of our Engineering team in the Fjernbane project – the project responsible for the introduction of a new signalling system based on ERTMS technology in Denmark. The Danish Signalling Programme, as the largest of its kind in Europe, is fully engaged replacing the old signalling system on the...
-
Software Consultant
1 month ago
København, Denmark Kardex Full timeKardex is a dynamic and innovative within the intralogistics and is dedicated to our values of Innovation, Respect, Passion and Teamwork. As we continue to grow, we are seeking a highly skilled and motivated Software Consultant/Application Specialist to join our talented team and contribute to our ongoing success. You need to be living in Denmark or Norway...
-
Software Consultant
4 weeks ago
København, Denmark Kardex Full timeKardex is a dynamic and innovative within the intralogistics and is dedicated to our values of Innovation, Respect, Passion and Teamwork. As we continue to grow, we are seeking a highly skilled and motivated Software Consultant/Application Specialist to join our talented team and contribute to our ongoing success. You need to be living in Denmark or Norway...
-
Model Risk Specialist to Group Internal Audit
2 weeks ago
København V, Denmark Danske Bank Full timeAre you an analytical thinker who is enthusiastic about financial services and eager to make a significant impact? Do you have an interest in model risk management and aspire to work in a learning environment? If so, we have an exciting opportunity for you to join our Model Risk team in Group Internal Audit.Model Risk Specialist to Group Internal Audit at...
-
Nomeco søger IT valideringsspecialist
3 months ago
København, Denmark Nomeco AS Full timeOm virksomheden Nomeco er den foretrukne lægemiddelgrossist for apoteker og hospitaler – ligesom vi er lægemiddelindustriens foretrukne strategiske servicepartner. Vi er specialister i sundhedslogistik, og sikrer at danskerne altid har rettidig adgang til lægemidler. Dette sker gennem et værdiskabende partnerskab med apoteker og lægemiddelindustri...
-
Nomeco søger IT valideringsspecialist
4 weeks ago
København, Denmark Nomeco AS Full timeOm virksomheden Nomeco er den foretrukne lægemiddelgrossist for apoteker og hospitaler – ligesom vi er lægemiddelindustriens foretrukne strategiske servicepartner. Vi er specialister i sundhedslogistik, og sikrer at danskerne altid har rettidig adgang til lægemidler. Dette sker gennem et værdiskabende partnerskab med apoteker og lægemiddelindustri...
-
Senior Model Risk Expert
1 month ago
København, Denmark Nordea Danmark, Filial af Nordea Bank Abp, Finland Full timeJob ID: 23916 Would you like to be part of a dynamic and multidisciplinary team of model risk experts and work with stakeholders across the entire Group? We are now looking for a Senior Model Risk Expert to further develop and strengthen Nordea’s model risk management framework and oversight.. At Nordea, we’re committed to being a partner our...
-
Solution Manager
4 weeks ago
København, Denmark Capax Recruitment ApS Full timeThe position is at PolyPeptide in Malmö About PolyPeptide PolyPeptide is one of the world’s leading contract manufacturers of therapeutic peptides for pharmaceuticals and cosmetics. They are a focused Contract Development & Manufacturing Organization (CDMO) for peptide- and oligonucleotide-based active pharmaceutical ingredients. By supporting their...
-
Solution Manager
1 month ago
København, Denmark Capax Recruitment ApS Full timeThe position is at PolyPeptide in Malmö About PolyPeptide PolyPeptide is one of the world’s leading contract manufacturers of therapeutic peptides for pharmaceuticals and cosmetics. They are a focused Contract Development & Manufacturing Organization (CDMO) for peptide- and oligonucleotide-based active pharmaceutical ingredients. By supporting their...
-
Supply Chain Specialist
4 weeks ago
København, Denmark Unicef Full timeUNICEF works in over 190 countries and territories to save children’s lives, defend their rights, and help them fulfill their potential, from early childhood through adolescence. At UNICEF, we are committed, passionate, and proud of what we do. Promoting the rights of every child is not just a job – it is a calling. UNICEF is a place where careers are...
-
Supply Chain Specialist
1 month ago
København, Denmark Unicef Full timeUNICEF works in over 190 countries and territories to save children’s lives, defend their rights, and help them fulfill their potential, from early childhood through adolescence. At UNICEF, we are committed, passionate, and proud of what we do. Promoting the rights of every child is not just a job – it is a calling. UNICEF is a place where careers are...
-
København, Denmark Unicef Full timeUNICEF works in over 190 countries and territories to save children’s lives, defend their rights, and help them fulfill their potential, from early childhood through adolescence. At UNICEF, we are committed, passionate, and proud of what we do. Promoting the rights of every child is not just a job – it is a calling. UNICEF is a place where careers are...
-
København, Denmark Unicef Full timeUNICEF works in over 190 countries and territories to save children’s lives, defend their rights, and help them fulfill their potential, from early childhood through adolescence. At UNICEF, we are committed, passionate, and proud of what we do. Promoting the rights of every child is not just a job – it is a calling. UNICEF is a place where careers are...
-
København, Denmark Unicef Full timeUNICEF works in over 190 countries and territories to save children’s lives, defend their rights, and help them fulfill their potential, from early childhood through adolescence. At UNICEF, we are committed, passionate, and proud of what we do. Promoting the rights of every child is not just a job – it is a calling. UNICEF is a place where careers are...