Do you have experience from biotechnology and tech transfer?

Biopharmaceutical Process Engineer

We are looking for a highly experienced Biopharmaceutical Engineer to be part of a well qualified and enthusiastic Diatec-team. The expansion of the team is driven based on the expansion of our facility to produce commercial cGMP material for a client while maintaining and expanding other parts of our business. The primary purpose of the position is to be the scientific and engineering leader for the tech transfer of our cGMP operations.

This is an exciting opportunity for you if you want to lead tech transfer, process validation and scale-up activities, as well as technically and scientifically support operations during a time of growth in the organization.

You will collaborate with development, supply chain and manufacturing for delivery of on-time and high-quality cGMP material to internal and external clients, and develop next generation processes partnered with development and clients.

Key responsibilities:

• Provide hands-on technical leadership to Manufacturing and other departments associated with GMP operations
• Lead activities to transfer processes from Development to Manufacturing
• Serve as manufacturing representative on client project teams; this includes the ability to interface extensively with the client
• Serve as a key development and manufacturing support on production team and be responsible for identifying, define and provide requirements for development and process equipment
• You will be the technical expert and serve as Subject Matter Expert to troubleshoot processes and equipment during investigations or lifecycle and process development in manufacturing and R&D
• Prepare and present data associated with manufacturing processes to internal and external clients. May serve as the escort during Person-in-Plant activities
• Build effective working relationships with QA, Process Development, Project Management to support current and new processes and products
• Use effective project management skills to ensure on-time project delivery
• Coaching and mentoring of staff in maintaining excellence on GMP, quality control, and safety

The Biopharmaceutical Process Engineer will work in the new expanded GMP Facility in Oslo Science Park where products for domestic and international markets are manufactured.

What we are looking for:

• Bachelor’s or Master’s degree in Biotechnology Engineering or Chemical Engineering and/or equivalent experience
• Minimum of 5 years’ experience in technology transfer, process validation and scale-up in a cGMP environment
• Excellent communication skills with the ability to communicate effectively within and outside the organization
• Demonstrated ability to think strategically and create on time and compliant solutions
• Thorough knowledge of cGMP regulations (ICH Q7A and 21CFR) as it applies to job function
• Experience working with Quality, Manufacturing Operations and Development
• Organizational and communication skills necessary to plan and execute work flow
• Excellent technical writer

The position reports to the Production Manager and Managing Director. The job title and level of compensation will reflect experience and qualifications.
We can offer you a challenging and exciting role in Norway in the growing field of pharmaceuticals and biotechnology.