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 Proposition
Employees 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:
Reporting to the relevant Manufacturing Manager, the
primary role of the Biotechnician is to perform day to day activities within
Cell Culture, Purification and Process Services within the Manufacturing Group.
They will be responsible for ensuring the manufacturing team has a successful
site start up, process validation and product launch activities.
Main areas of responsibility:
- Performing, monitoring and troubleshooting of the cell
culture, purification or support operations within Manufacturing. - Monitoring and reporting of process performance using
statistical process control. - Support of Commissioning and Qualification activities.
- Preparation, updating and execution of Batch Records,
SOPs and other GMP documentation. - Provide process and equipment related training as
required within the Manufacturing Department. - Troubleshooting of process specific equipment.
- Troubleshooting of DCS (e.g. Delta V) and PLC control
systems. - Authoring, investigating and resolving quality deviations
raised within the Manufacturing Department. - Participate in/ Lead Cross Functional team initiatives
when required. - Participate in the execution of validation protocols.
- Demonstrate an active approach to safety, industrial
hygiene, environmental and regulatory compliance. - Completion of assigned tasks to support manufacture of
quality biopharmaceuticals in accordance with cGMP and EHS requirements. - Use Right First Time (six-sigma) and lean manufacturing
practices leading to operational excellence. - Working flexible shift patterns 2 Shift Rota (8hr) to
meet business needs and Manufacturing schedule
Requirements
Skills:
- Should be proficient in the operation of all equipment
used in the respective functional area of responsibility.
Education:
- Bachelor degree in Biotechnology, Chemical or Biochemical
Engineering, Biochemistry or Bio-systems Engineering or related field or
equivalent experience is preferred.