Job Description

　　Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing efficiency in their laboratories, we are here to support them. Our distributed team of more than 130,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com .

　　About Norway

　　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.

　　How will you influence?

　　Technical operations

　　You will be responsible for improving 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 improvements within the framework of ISO 13485.

　　Facilities and EHS

　　You will have responsibility for facilities projects and safety installations as well as operational support. You will work closely with all other functions in the company, e.g. R&D, Manufacturing, QA/QC and TechOps. You will work with our facilities, utilities and various projects.

　　What will you do?

　　Technical operations:

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

　　Data Analysis: Collect and analyze data from production runs to identify trends, solve issues, and make data-driven decisions to improve processes.

　　Process subject matter expert: Perform impact assessment, root cause investigations, and establish effective corrective/preventive actions to solve underlying root cause in deviation handling related to production processes and process safety.

　　Technical Operations projects: Responsible for capacity and practical process improvement projects to drive growth and ensure process safety.

　　Facilities and EHS:

　　Facilities projects: Responsible for facilities projects and safety installations, management of new construction/renovation projects and ensure EHS requirements and regulations.

　　Installation management: Lead contractors to facilitate timely installation of new utilities and facility modifications.

　　Maintenance management: Follow up and develop predictive maintenance plans for facilities and production equipment.

　　Equipment subject matter expert: Equipment breakdowns handling, report and handle deviations and contribution to interdisciplinary investigations.

　　General:

　　Continuous Improvement: Lead and participate in process improvement initiatives, including the introduction of new technologies and methods to enhance production and 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: 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?

　　Education and experience

　　Bachelor/ Master of Science or higher within chemical engineering, mechanical engineering, or a related field.

　　Expected experience for Sr. Engineer: Experience as project manager and more than 7 years of experience from process industry.

　　Desired experience for Engineer: 5 years of experience or more within process industry. Newly graduated candidates will also be evaluated.

　　Qualifications

　　Facilities and EHS:

　　Engineering experience within areas like mechanical, electrical and instrumentation or piping.

　　Skilled engineer who has a good understanding of building management system, HVAC, maintenance, and servicing.

　　Technical operations:

　　Process engineering experience from industrial process facility preferably in the context of batch production processes.

　　Skilled chemical process engineering preferably with knowledge in one or more of the following fields: Process technology, chemistry, surface and colloid chemistry, organic chemistry, or polymer chemistry.

　　General:

　　Experience with commissioning and qualification, preferably according to ISPE guideline

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

　　Nice to have qualifications:

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

　　Experience with process automation and control systems.

　　Experience performing computer software validation.

　　Proficiency in data analysis and statistical tools.

　　Knowledge of process simulation software (e.g., Aspen plus) preferably in the context of batch production.

　　Personal attributes

　　Fluent in both spoken and written English and a Scandinavian language with excellent technical writing skills.

　　Strong analytical and problem-solving 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.

　　An excellent teammate with the ability to give/receive constructive feedback.

　　Dedication to excellence within safety and quality.

　　We look forward to receiving your application, including a cover letter and CV in English (in one document for easy upload). Please apply via http://jobs.thermofisher.com/ by 11th of February. R-01208002. Please apply as soon as possible, the positions will be filled as soon as suitable candidates are found.

　　If you have questions about the position and/or Thermo Fisher Scientific – Petra Norrman, Recruiter Nordics, [email protected].

　　At Thermo Fisher Scientific, each one of our 130,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

　　Apply today! http://jobs.thermofisher.com

　　Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.