This role is an 11 Month contract with a view to extension.
A unique opportunity for the right person In this ambitious project, the Senior Process Specialist Engineer role will be essential in ensuring efficient and effective compliant design, construction, qualification, approval, and operation of the new state-of-the-art facility during the initial project phase. The successful candidate will take a lead in utilising the latest innovations in technology.
• Support the design, construction, and qualification of upstream & downstream equipment on-site through technology transfer and commercialization.
• Support establishment of the commercial process and routine manufacturing.
• Supporting experimental design, execution, data analysis, and interpretation.
• Interpreting trends observed in commercial process monitoring (e.g., proactive process analysis (PPA), continued process verification (CPV), statistical process control (SPC) multivariate analyses (MVDA)), and for further technical investigations and process changes that seek to drive improvements to yield and/or robustness.
• Supporting deviation management.
• Supporting change control prioritization and implementation.
• Reviewing and authorising batch documentation, technical reports, and global regulatory submissions.
• Supporting multidisciplinary teams (manufacturing science and technology, quality, analytics, regulatory) for process improvement and troubleshooting with an end-to-end product focus.
• Applying Lean Six Sigma tools by Securing continuity of an appropriate LSS/CEM level of knowledge.
• Facilitating problem-solving & risk assessment (FMEA) projects/meetings.
• Making problems visible and striving for continuous improvement.
• Serving as a key member during internal audits and external inspections/audits.
• Lead and support various manufacturing science and technology organizational initiatives as needed (examples include safety, financial forecasting, work standardization, etc).
• Maintain continuous focus on quality and safety compliance and unflinching focus on the customer.
• This role may require shift work support after the facility start-up phase is complete.
• Bachelor’s degree (or higher) in Biological Sciences/Chemical Engineering/Biological Engineering/Chemistry (or PhD without industry experience).
• minimum of 5 years of experience (for MSc) or 7 years of experience (for BSc) directly related experience in academia, pharmaceutical, or biotechnology company – along with a working knowledge of current regulatory requirements and current Good Manufacturing Practices.
• strong contemporary knowledge, and the ability to work independently and on multidisciplinary teams.
• demonstrated ability to deliver what is needed on time, holding self and team accountable for commitments, decisions, actions, and behaviour.
• excellent oral and written communication skills, with the ability to effectively articulate an understanding of process science, in order to drive decision making, impact assessments, design of studies, etc., in a multi-disciplinary team environment.
• show ambition and drive to develop and advance their career within MSD.
• Experience with upstream cell culture and/or downstream purification of biological molecules. Experience with technology transfer, regulatory filing, and commercial drug substance manufacturing of biologics is a plus.
• Technical operations experience in the drug substance manufacture of biological molecules at a commercial scale.
• Prior experience in drug substance process development, process characterization studies, process performance qualification, and validation, site readiness, batch record reviews, authoring regulatory CTD sections, and/or working with external contract organizations for the development and/or manufacturing.
• Working knowledge of statistical methods for DOE design and data analysis (e.g.,
JMP or Design Expert software)
• Working knowledge of statistical process control (SPC), multivariate analysis (MVDA).
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