Industry Pharma/Biotech/Clinical Research
Work Experience 4-5 years
City Cork
State/Province Cork
Country Ireland
Job Description
About PSC Biotech
Who are we?
PSC Biotech is a leading Biotech Consultancy firm foundedin ****, headquartered in Pomona, California, USA, with Global operations inIreland, India, Singapore, Australia and the US, serving 350 clients in morethan 23 countries worldwide.
We provide cloud-based software solutions forQuality Management and Regulatory Inspections, pharmaceuticals contractmanufacturing professionals, and metrology services to our clients.
'Take your Career to a new Level'
PSC Biotech disrupts the conventional consultancy modelby aligning our EVP as one of the unique selling point which includes theopportunity to work with the most talented cohort of like-minded professionalsoperating in the Pharma/ Biotech Industry.
We offer a permanent contract ofemployment giving exposure of working in Top Pharmaceutical client sites in adiverse-cultural work setting.
Employee Value Proposition
Employees are the "heartbeat" of PSC Biotech, we provideunparalleled empowering career development though Learning & Developmentin-house training mentorship through constant guidance to facilitate careerprogression.
We believe in creating high performing teams that can exceed ourclient's expectations with regards to quality of all scalable and business unitdeliverables, staying under budget and ensuring timelines for our deliverablesare being met.
Overview:
Reporting to the relevant Manufacturing Manager, theprimary role of the Biotechnician is to perform day to day activities withinCell Culture, Purification and Process Services within the Manufacturing Group.They will be responsible for ensuring the manufacturing team has a successfulsite start up, process validation and product launch activities.
Main areas of responsibility:
Performing, monitoring and troubleshooting of the cellculture, purification or support operations within Manufacturing.
Monitoring and reporting of process performance usingstatistical 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 asrequired within the Manufacturing Department.
Troubleshooting of process specific equipment.
Troubleshooting of DCS (e.g. Delta V) and PLC controlsystems.
Authoring, investigating and resolving quality deviationsraised within the Manufacturing Department.
Participate in/ Lead Cross Functional team initiativeswhen required.
Participate in the execution of validation protocols.
Demonstrate an active approach to safety, industrialhygiene, environmental and regulatory compliance.
Completion of assigned tasks to support manufacture ofquality biopharmaceuticals in accordance with cGMP and EHS requirements.
Use Right First Time (six-sigma) and lean manufacturingpractices leading to operational excellence.
Working flexible shift patterns 2 Shift Rota (8hr) tomeet business needs and Manufacturing schedule
Requirements
Skills:
Should be proficient in the operation of all equipmentused in the respective functional area of responsibility.
Education:
Bachelor degree in Biotechnology, Chemical or BiochemicalEngineering, Biochemistry or Bio-systems Engineering or related field orequivalent experience is preferred.
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