Validation Engineer - solutions for the medical and pharmaceutical industries | AMBIZZION

Do you see yourself playing a crucial role in ensuring that products, systems, and processes meet specified requirements and standards before released to the market or implemented? Are you experienced in validation, quality assurance, project management or a related role, and do you see yourself becoming part of a healthy company with great potential for continued growth?
Our client, SPT Vilecon are developing new products and improving/ optimizing existing products and production lines in close dialogue with customers and partners. SPT VILECON also offers consultants for production support, optimization, validation, project management and quality assurance just to name a few. The customers are often the leading international companies in their specific field. SPT Vilecon is now facing strong business opportunities.

Position:
As Validation Engineer in SPT Vilecon you play a crucial role in ensuring that products, systems, and processes meet specified requirements and standards before released to the market or implemented. The Validation Engineer ensures that products, equipment, systems, and processes comply with regulatory requirements, industry standards, and company-specific guidelines. This role involves developing and executing validation plans, conducting tests, and documenting results to confirm compliance and functionality.

Key Responsibilities:

• URS, DQ, FAT, SAT, IQ, OQ, PQ
• Develop validation protocols for systems, equipment and/or processes
• Execute qualification protocols for installation (IQ), operational performance (OQ) and performance load (PQ)
• Execute risk assessments and gap analyses on systems or processes, FMECA, Hazard
• Ensure documentation complies with industry regulations (e.g., FDA, ISO, GMP)
• Identify and report any validation deviations and propose corrective actions in collaboration with QA functions

You ensure all validation activities align with applicable regulatory requirements (e.g., FDA 21 CFR Part 11, ISO 9001, ISO 13485). You collaborate with Quality Assurance and Regulatory Affairs teams to ensure and maintain compliance. You work closely with R&D and manufacturing to integrate validation processes into project development workflows as well as you continously analyze validation processes to identify opportunities for improvement.

About you:
You have minimum +6 years of experience in validation, quality assurance, or a related role in industries such as MedTech, pharmaceuticals, biotechnology, medical devices or manufacturing.

You have a min Bachelor´s degree in Engineering (e.g. mechanical engineering, production engineering or similar). You have gained experience with designing and executing tests, writing and reviewing scientific content with a high technical complexity, and you are familiar with production (including GMP and QA).

Technical Skills

• Proficiency in validation tools and software
• Knowledge of regulatory standards (FDA, GMP, ISO, etc.)
• Familiarity with statistical analysis and risk assessment programs
• Maybe you are familiar with equipment commissioning (URS, risk management, FAT/SAT, validation and operating/maintaining of equipment and moulds)
• Project management

You have analytical and problem-solving abilities. You are self-driven, action- and detail-oriented and you can navigate professionally in and dynamic environment. You have a positive attitude. Due to your strong communication and interpersonal skills and your approach to planning, you ensure progress in a complex and interdisciplinary environment. You are fluent in English (both in verbal and in writing).

That´s what you get:
You get great opportunity to make an impression on your job function and your daily work. The policy of SPT Vilecon is always to meet customers′ requirements and expectations. It is an international company with flat structure, short decision-making paths. There is an ambitious atmosphere and pioneering spirit in the workplace. Focus on developing new products and improving/ optimizing existing products and production lines in close dialogue with customers and partners. The team (today about 40 people) consists of dedicated engineers, technicians and sales representatives, all of whom are highly qualified within their specific professions.

SPT Vilecon is now facing very strong business opportunities, by delivering future-proof medtech solutions, which are based on specific customer requirements.

Read more: https://www.sptvilecon.com

The place of work is in Hedehusene. A big portion of the work will be carried out at customers.

Next step:
Send your application and CV via the link below “søg stillingen.” The position is desired to be filled as soon as possible, so applications are processed on an ongoing basis. Feel free to call AMBIZZION, Peder Vester Henriksen – mobile +45 5329 6929.

Er det her job dig?
Søg stillingen

Ansvarlig
Direktør/Partner Peder Vester Henriksen
+45 53 29 69 29 · [email protected]

Backup
Senior Partner Jens Carøre Sørensen
+45 21 47 40 10 · [email protected]