Process Engineer

ref. 01111

Process Engineer

Role
Construction of a new Large scale Mammalian – Based Drug Substance Facility. The successful candidate will have the opportunity to work in a very exciting and ambitious project, ensuring the efficiency and efficacy of the process through design, construction, qualification, and operation of the new facility during the initial project phase.

Responsibilities
• The Process Engineer is responsible for introducing new processes and/or products (product transfer).
• Development and transfer knowledge of Lean Six Sigma, Change Management and Inclusion, ensuring effective application of these tools by leading projects, facilitating kaizens and coaching sponsors and practitioners.
• Responsible for supporting design, construction and qualification of upstream and downstream equipment in a Large scale Drug Substance Facility.
• Support the settlement of the routine manufacturing and commercial process through:
>Supporting the management of deviation
>Interpretation of the tendencies observed in commercial process monitoring (e.g., proactive process analysis (PPA), continued process verification (CPV), multivariate analyses (MVDA) statistical process control (SPC))
>Gives support to multidisciplinary teams, such as manufacturing science and technology, analytics, quality, regulatory, for improvement of process and troubleshooting with end-to-end product focus.
>Responsible for authorization and reviewing of technical reports, batch documentation and global regulatory compliance.
>Continuous focus on quality and safety submissions.
>Leadership and support of manufacturing and organizational initiatives as necessary (including financial forecasting, safety, work standardization, and others)

Skills
• A can-do attitude and results-focused
• Minimal work direction needed
• Ability to work independently and in a team work
• Have excellent oral and written communication skills, with the ability to effectively articulate understanding of process science
• A proven track record in delivering excellence.

Qualification/Experience
• 5+ years (for MSc) or 7+ years (for BSc) directly related experience in academia, pharmaceutical or biotechnology company with a working knowledge of cGMP and current regulatory requirements.
• Bachelor’s degree (or higher) in Biological Sciences/Biological Engineering/Chemical Engineering/Chemistry (or PhD without industry experience)
• Experience with technology transfer, regulatory filing, and commercial drug substance manufacturing of biologics is a plus.
• Working knowledge of statistical process control (SPC), multivariate analysis (MVDA), statistical methods for DOE design and data analysis (e.g., JMP or Design Expert software)
• Prior experience with drug substance manufacture of biological molecules at commercial-scale, process development, batch records reviews, process performance qualification and validation, regulatory CTD sections and/or working experience with external contract organization.