Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
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 collaboration 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.
We are now looking for a new colleague to join the manufacturing sciences department, a part of Technical Operations, where we offer an outstanding possibility to work with production processes for one of the most exciting technologies within biotechnology. Our work is both exciting and challenging in an international environment with large opportunity for professional and personal growth.

How will you influence?

You will be responsible for ensuring efficient and effective transfer and validation of processes from lab scale to commercial scale, optimizing and improving our manufacturing processes, ensuring product quality, and driving efficiency in our production systems. You will collaborate with multi-functional teams to design, implement, and supervise process validation and improvements within the framework of ISO 13485.

What will you do?

• Process Optimization: Analyze existing manufacturing processes, identify areas for improvement, and implement changes to enhance efficiency, reduce waste, and ensure product quality while maintaining ISO 13485 compliance.
• Continuous Improvement: Participate in process improvement initiatives, including the introduction of new technologies and methods to enhance production.
• Project management: Participate in improvement or NPI projects according to a phase gate approach and communicate efficiently with stakeholders.
• Quality Assurance: Develop and implement quality control procedures to ensure that products meet or exceed ISO 13485 standards, industry regulations, and customer expectations.
• Equipment Evaluation: Evaluate and recommend equipment upgrades or replacements to improve process efficiency and reliability.
• 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.
• Multi-functional collaboration: Collaborate with production, facilities, EHS, R&D and quality assurance teams to ensure alignment on process improvements and quality standards.
• Safety Compliance: Adhere to all safety protocols and procedures, ensuring safety in production processes, a safe working environment and compliance with regulatory standards.

Requirements:

• Bachelor/ Master of Science or higher within chemical engineering, industrial biotechnology, or a related field.
• Experience in medical device manufacturing or an industrial process facility.
• Strong analytical and problem-solving skills.
• Fluent in both spoken and written English and a Scandinavian language with excellent technical writing skills.
• Ability to work, communicate and influence efficiently with impactful multi-functional teams in a matrix organization.
• Interest and understanding of the importance of documented quality.
• Results oriented with a high energy, and drive. Adapt quickly to changes and re-prioritizations with a positive demeanor.
• A great teammate with the ability to give/receive constructive feedback.
• Diligent with a dedication to safety and quality.

Nice-to-haves:

• Experience with Quality by Design and Life Cycle approach to Process Validation
• Familiarity with ISO 13485 regulatory requirements specific to the medical device industry or comparable quality management system.
• Experience participating projects within process, biotechnology, or polymer industries preferably within the context of ISO 13485 quality system or similar.

What we offer:

• A truly supportive and diverse team
• Opportunities for interesting project work
• A job that brings lots of learning!

Thermo Fisher Scientific offers employment in an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation! We have an annual incentive plan bonus, healthcare, and a range of other employee benefits.