Validation Specialist
Black Swans Exist ApS
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
[email protected]
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