Sr Facilities Specialist

Work Schedule

Environmental Conditions

Job Description

Dynabeads produced in Norway are used in break-through technologies, lifesaving assays and clinical applications. Our customers are world leading pharma and diagnostics companies that have chosen us as their partner. Through a strong culture of teamwork both internally and externally, we deliver on high expectations through the quality of our work. Measuring quality in a reliable way is a key requirement from customers and regulatory authorities alike.

Position summary

The main area of responsibility will be to join the Facilities department to support daily operations activities as well as to ensure project planning, execution and follow up according to company needs and to ensure safety, reliability, and our goals.

This is an opportunity to work with equipment and infrastructure, production processes, facilities and EHS in relation to one of the most exciting technologies within biotechnology, and in an international environment.

Continuous Improvement: participate in process improvement initiatives related to maintenance and projects to improve production and safety

Contribute to and support impact assessments and investigate root causes to address deviations in equipment and production process

Quality Assurance: following quality control procedures to ensure products meet or exceed ISO 13485 standards, industry regulations, and customer expectations.

Documentation: Maintain comprehensive documentation of process changes, equipment specifications, Mechanical Completion/commissioning, equipment qualification, and standard operating procedures while adhering to documentation requirements.

Safety Compliance: Adhere to all safety protocols and procedures, ensuring safety in production processes, a safe working environment, and compliance with regulatory standards.

How will you get there?

Qualifications

• Bachelor or master in mechanical-engineering and/or experience within process/chemical- engineering, or a related field

• Engineering experience from industrial process and equipment, preferably in the context of batch production processes

• Experience from project execution. Project management experience is an advantage

• Proficient in both spoken and written English and Norwegian language with excellent technical writing skills

• Familiarity with ISO 13485 regulatory requirements specific to the medical device industry or comparable quality management system is advantageous

Personal attributes

• Proficient in initiating, executing, and finalizing tasks both independently and as part of a team

• Dedication to excellence within safety and quality

• Strong analytical and problem-solving skills

• Ability to work, communicate, and influence efficiently with impactful multi-functional teams in a matrix organization!

What we offer

• 
  Great development opportunity within a range of disciplines (mechanical processes, automation, etc.)

• Being part of a positive team working environment with good peer support

• Varied job and tasks and good benefits!

Please note that this position will be filled as soon as a suitable candidate is found. We look forward to receiving your application!

Diversity in our teams is an important element to building an inclusive and challenging working environment. Integrity, Intensity, Innovation, and Involvement are the key 4i values of our global community.