• Type of Employment: temporary through nemensis ag, 100%
• ID: 22169
• Duration: 02.01.2025 - 31.12.2025 
• Salary: CHF 51,- /h - CHF 63,- /h

For our client, a pioneering company in the development and manufacture of large molecule drugs, we are looking for a highly motivated Engineer in External Manufacturing within the Drug Substance Technical Operations Unit. This role offers an exciting opportunity to support the transfer and commercial manufacture of drug substances in collaboration with strategic external partners, gaining technical expertise in biologics or vaccine manufacturing while contributing to high-visibility network initiatives.

Responsibilities:

• Collaborate with external partners to achieve shared goals and foster a cooperative culture.
• Serve as the primary technical contact between Technical Operations and external drug substance manufacturers.
• Oversee technology transfer activities, including authoring and reviewing required GMP documentation (e.g., Master Batch Records, change controls, protocols, reports).
• Lead technical activities for commercial manufacturing processes, including change control, process improvement projects, statistical process analysis, and investigation of deviations.
• Develop innovative solutions to complex technical issues, applying principles and standards of sterile manufacturing.
• Provide on-site support at external partners' facilities to assist with commercial production and technology transfer activities.
• Ensure external partners are inspection-ready for routine inspections and new product introductions, in coordination with Operations, Quality, and Regulatory teams.
• Participate in the creation, sharing, and adoption of best practices and business process strategies.

Requirements:

• Bachelor's degree in Chemical/Biochemical Engineering, Pharmaceutical Science, Chemistry/Biology, or a related scientific or engineering discipline.
• Minimum of 5 years of experience in a GMP environment or supporting a GMP functional area, such as Operations, Technical Operations, Technology, or Engineering.
• Strong ability to work independently with excellent organizational skills.
• Excellent interpersonal and communication skills.
• Ability to multitask effectively within tight deadlines.
• Solid analytical skills, including problem-solving, root cause analysis, and risk assessment.
• Proven team-building skills.
• Fluent in English (both written and spoken).
• Willingness to travel (approximately 25%).
• Criminal Record needed.

Preferred Qualifications:

• Experience in biologics manufacturing.
• Knowledge of ADC manufacturing.
• Project management experience.
• Familiarity with deviation management, change control, or equipment support.
• Knowledge of global regulatory requirements and experience supporting regulatory inspections.

Benefits with nemensis ag:

• Nemensis ag is your specialized recruitment agency in the Life Sciences sector, based in Basel.
• Comprehensive consultation and support throughout the application process by our consultants.
• Access to a broad client network and exciting opportunities in Northwestern Switzerland.
• Quick and easy onboarding through personalized guidance and support during the application process.

Sound like you? Then let's go! We look forward to your application.

About Us

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Contact: Kristina Mutidi, Write an email

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