Manufacturing Scientist, Injectable Devices

3 weeks ago

Uppsala, Sweden Q-Med AB Full time

Job Title: Manufacturing Scientist, Injectable Devices

Location: Uppsala, Sweden (on site)



Job description :

We are looking for a new member to the Device injectables team within Manufacturing Science and Technology. The manufacturing scientist is a subject matter expert (SME) responsible for new product implementation (NPI) into a manufacturing facility, and for support of upstream processes during commercial manufacturing.



Key responsibilities:

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Support new product implementation (NPI) strategy and all aspects of process validation, including process data reviews, investigations, risk management, and change implementation. Write validation documentation and execute process validation under guidance from senior scientists.
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Serve as a technical SME representing MS&T in Technology Transfer projects.
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Process owner to support day-to-day operations with a focus on continuous improvements. Identify opportunities for process enhancement, cost reduction, and efficiency gains, proactively driving necessary changes.
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Lead and participate in investigations into deviations, incidents, and anomalies within the manufacturing process. Conduct in-depth root cause analysis to identify the underlying reasons for deviations and incidents, focusing on process improvement.
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Collect data from various sources, including quality control reports, production logs, and other relevant documents, to support investigations and continuous process verification (CPV)
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Write and review technical documentation ensuring compliance with regulatory and quality standards.
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Coordinate with other experts and collaborate with cross-functional teams, including production, quality assurance, regulatory affairs, and process development, to ensure thorough investigation and timely issue resolution. Assist senior scientists in information gathering to support research studies and claims, and provide input to risk assessments/FMEAs.
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Prepare detailed investigation reports, conveying findings and recommendations to management and relevant stakeholders





Skills & Qualifications

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BSc or MSc degree in a relevant engineering field
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Good familiarity with upstream manufacturing processes in the medical device and/or biopharmaceutical industry
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1 to 3 years of experience in upstream operations, preferably in a biopharmaceutical/medical device manufacturing environment
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Strong knowledge of investigative methodologies and root cause analysis techniques
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Knowledge of regulatory requirements related to investigations and cGMP
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Sterilization knowledge is meriting





What we offer in return

You will be working for an organisation that embraces diversity & inclusion and believe we will deliver better outcomes by reflecting the perspectives of our diverse customer base.



As Galderma's Global Center of Excellence for Aesthetics we have in Uppsala a unique edge as we have on our site the whole product chain from research and development to production and marketing. Here our nearly 600 employees work on our world leading brands such as Restylane, Azzalure and Sculptra.



We are offering you the opportunity to work in an exciting, international environment where both professional and personal development is encouraged. We are based in modern offices and located just by the river (Fyrisån) in Uppsala only a 10 minute bike ride from Uppsala Central Station.



Next steps

We welcome your application via our company website CAREERS | Galderma. Apply as soon as possible, as the selection process is ongoing continuously.

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If your profile is a match, we will invite you for a first virtual conversation with the recruiter.
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The next step is an interview with the hiring manager
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The final step is a panel conversation with the extended team



Our people make a difference

At Galderma, you'll work with people who are like you. And people that are different. We value what every member of our team brings. Professionalism, collaboration, and a friendly, supportive ethos is the perfect environment for people to thrive and excel in what they do.

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