Industry Pharma/Biotech/Clinical Research
Work Experience 1-3 years
City Dundalk
State/Province Louth
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:
We are looking for a BioProcess Associate – to join ourDrug Substance team at our state-of-the-art, fully integrated vaccine facilityin Ireland.
As a Bioprocessing Associate, you will be a key member in ourfast-growing, dynamic startup-working with cutting-edge technology.
Requirements
Responsibilities:
Manufacturing processes include DS Downstream Processing(DSP) and Upstream Processing (USP) and Buffer / Media preparation
Carry out all production operations in the assigned areaas per the relevant SOPs and Manufacturing Batch Records .
Assist in maintaining a safety orientated Culture, cGMPcompliant work environment at all times
Write, review and revision of area Standard OperatingProcedures (SOPs), On the Job Training (OJT's), Production Batch Records(PBRs), Logbooks, Training Competencies and Work Instructions
Training and mentoring of colleagues in SOPs, processexecution and equipment operation.
Support Manufacturing team to consistently deliver onspecific area Key Performance Indicators (KPIs), e.g. Safety, Quality, Scheduleadherence, Overall Equipment Effectiveness (OEE), and team training.
Assist with the investigation of and operationsdeviations through Quality System, engaging with all relevant personnel andfunctions as appropriate.
Lead and actively participate in shift handovers.
Liaise with Shift Lead regarding issues which may arisewithin the production area including highlighting of operational challenges.
Use Lean Tools as part of daily operations (StandardWork, 5S, TPM, Gemba, Method 1,) to optimize efficiency and drive the cultureof Continuous Improvement (CI)
Support HAZOP and risk assessments as per requirements.
Provide assistance and/or support maintenance,engineering, quality or other colleagues as requested.
Conducts all activities that are in accordance withCompany policies & SOPs & global regulatory guidelines (includingcGMP/cGLP/cGCP), environmental guidelines, as appropriate.
Support the development, commissioning &qualification of a new vaccines drug substance manufacturing equipment andsubsequent transition to commercial manufacturing.
What skills you will need:
Demonstrated experience in Bioprocessing, Upstream orDownstream.
Knowledge and experience of relevant cGMP, safety, andenvironmental regulations within the biopharmaceutical industry.
High level of adaptability working in a fast-pacedenvironment and champion change.
Experience with recording information in real time usingelectronic or manual systems.
Experience in executing operations while following SOPs,Batch Records and Manufacturing Controls Systems.
Experience of working in Grade C, D and CNC environmentis an advantage.
Excellent interpersonal skills, positive influence, teamorientation, attention to detail, documentation skills, problem identificationand problem-solving skills.
An ability to work independently, and as a member of aself - managed shift team in a dynamic, fast-paced environment that requiresflexibility and initiative.
Shift Pattern:
This position will initiallyoperate standard office hours Monday-Friday but will be transition in Extended 7-day shift patternwith 12-hour shifts, designed to provide 24/7 coverage using a 4-week repeatingcycle.
Two teams rotate through this schedule
Example :
Week 1: Work Monday, Tuesday, Friday, Saturday, Sunday (12-hour day shifts), Off Wednesday and Thursday
Week 2: Work Wednesday and Thursday only, Off the other 5 days
Week 3: Same as Week 1: Work Monday, Tuesday, Friday, Saturday, Sunday
Week 4: Same as Week 2: Work Wednesday and Thursday only
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