Process Scientist, Manufacturing Innovations
2 weeks ago
Job Summary
We are seeking a skilled Process Scientist to join our manufacturing sciences department in Technical Operations. As a key member of our team, 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.
Key Responsibilities
- Analyze existing manufacturing processes to identify areas for improvement and implement changes to enhance efficiency, reduce waste, and ensure product quality while maintaining ISO 13485 compliance.
- Collaborate with multi-functional teams to design, implement, and supervise process validation and improvements within the framework of ISO 13485.
- Evaluate and recommend equipment upgrades or replacements to improve process efficiency and reliability.
- Maintain comprehensive documentation of process changes, equipment specifications, commissioning, equipment qualification, process validation, and standard operating procedures while adhering to ISO 13485 documentation requirements.
- Collaborate with production, facilities, EHS, R&D, and quality assurance teams to ensure alignment on process improvements and quality standards.
Requirements
- Bachelor or 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, adapting quickly to changes and re-prioritizations with a positive demeanor.
- A great teammate with the ability to give and 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 in projects within process, biotechnology, or polymer industries preferably within the context of ISO 13485 quality system or similar.
About Us
We offer a truly supportive and diverse team, opportunities for interesting project work, and 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.
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Lillestrøm, Viken, Norway Thermo Fisher Scientific Full timeJob Title: Process Scientist, Technical OperationsThermo Fisher Scientific is seeking a highly skilled Process Scientist to join our Technical Operations team. As a key member of our manufacturing sciences department, you will be responsible for ensuring efficient and effective transfer and validation of processes from lab scale to commercial scale.Key...
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