About PSC Biotech Who are we?PSC Biotech is a leading Biotech Consultancy firm founded
in 1996, headquartered in Pomona, California, USA, with Global operations in
Ireland, India, Singapore, Australia and the US, serving 350 clients in more
than 23 countries worldwide. We provide cloud-based software solutions for
Quality Management and Regulatory Inspections, pharmaceuticals contract
manufacturing professionals, and metrology services to our clients. ‘Take your Career to a new Level’PSC Biotech disrupts the conventional consultancy model
by aligning our EVP as one of the unique selling point which includes the
opportunity to work with the most talented cohort of like-minded professionals
operating in the Pharma/ Biotech Industry. We offer a permanent contract of
employment giving exposure of working in Top Pharmaceutical client sites in a
diverse-cultural work setting. Employee Value PropositionEmployees are the “heartbeat” of PSC Biotech, we provide
unparalleled empowering career development though Learning & Development
in-house training mentorship through constant guidance to facilitate career
progression. We believe in creating high performing teams that can exceed our
client’s expectations with regards to quality of all scalable and business unit
deliverables, staying under budget and ensuring timelines for our deliverables
are being met. Overview:An exciting opportunity has arisen for a MS&T Senior
Bioprocess Engineer.RequirementsRole Functions:Responsible for the participation in and leading of key
technology transfers activities, in support of clinical and commercial new
product introduction projects.Development of strategies for and support in the
execution of technology transfer, process and clean validation programs in line
with company, industry and regulatory standards.Acting as process Subject Matter Expert in the support of
process investigations.Use of risk management techniques to assess strategies,
prioritize activities and initiatives.Lead other significant business critical projects on site
associated with new product introduction and site capability build.Acting as system owner and Subject Matter Expert (SME) to
support investigations and using risk management techniques to prioritize
activities and initiatives.Ongoing optimization of process equipment and development
of future breakthrough business solutions. Experience, Knowledge & Skills:Minimum of 6 years in a biologics drug substance
environmentTechnical expertise in biological drug substance upstream
and/or downstream purification unit operations required.Experience in technology transfers for clinical or
commercial biologics strongly desired.Experience with automated systems highly desiredProcess validation and cleaning validation experience
desired. Qualifications & Education:Minimum of a Bachelor’s Level 8 degree in a technical
field (e.g. Engineering, Science or equivalent), with experience in the
biotechnology or pharmaceutical industry. #LI-AP1