Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

The role

The main area of be responsibility will be within the ongoing improvement of manufacturing processes, ensuring product quality, and driving efficiency in our production systems, in collaboration with multi-functional teams to design, implement, and supervise process improvements within the framework of ISO 13485.

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

This 12-month position will provide a good balance between hands-on work in the field, i.e. in a laboratory setting or in an industrial process plant, liaising with operators and observing, with an aim to improving the way that we work. The job also involves working in an office environment, to do planning, risk analysis, change assessments, documentation, etc. Additionally, you would take part in various project work and have regularly collaborations with other departments.

Responsibilities

Process Optimization: Analyze existing manufacturing processes, identify areas for improvement, and implement changes to improve efficiency, reduce waste, and ensure product quality.

Technical Operations projects: Participate in capacity and practical process improvement projects to drive growth and ensure process safety.

Quality Assurance: Develop and implement 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, MC/commissioning, equipment qualification, process validation and standard operating procedures while adhering to ISO 13485 documentation requirements.

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

QualificationsBachelor/ Master of Science or higher within process/chemical -, mechanical-, automation- or a related engineering fieldFluent in both spoken and written English and a Scandinavian language with excellent technical writing skillsMin experience: 2 years experience in industry, preferably in the context of chemical batch production processesExperience with commissioning and qualification, preferably according to ISPE guidelinesExperience from project execution. Project management experience is an advantageFamiliarity with ISO 13485 regulatory requirements specific to the medical device industry or a comparable quality management system would be a clear advantageExperience with process automation and control systems would be beneficialPersonal attributesAble to start, implement and finalize working task independently as well as part of teamDedication to excellence within Safety and QualityStrong analytical and problem-solving skillsAbility to work, communicate and influence others in multi-functional teams within a matrix organizationResults oriented with a high energy, and driveAn excellent teammate with the ability to give/receive constructive feedback.What we offerMeaningful work with a real impact, globally!A collaborative and supportive team environmentGreat variety of social groups and local benefitsAnnual incentive bonus

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.

Diversity in our teams is an important element to build an effective and challenging working environment. Integrity, Intensity, Innovation, and Involvement are key values that we expect of all that are part of our community.

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