Bioprocess Associate -Shift

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:

We are looking for a BioProcess Associate – to join our
Drug Substance team at our state -of -the -art, fully integrated vaccine facility
in Ireland. As a Bioprocessing Associate, you will be a key member in our
fast -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 area
  as per the relevant SOPs and Manufacturing Batch Records .
  
• Assist in maintaining a safety orientated Culture, cGMP
  compliant work environment at all times
  
• Write, review and revision of area Standard Operating
  Procedures (SOPs), On the Job Training (OJT’s), Production Batch Records
  (PBRs), Logbooks, Training Competencies and Work Instructions
  
• Training and mentoring of colleagues in SOPs, process
  execution and equipment operation.
  
• Support Manufacturing team to consistently deliver on
  specific area Key Performance Indicators (KPIs), e.g. Safety, Quality, Schedule
  adherence, Overall Equipment Effectiveness (OEE), and team training.
  
• Assist with the investigation of and operations
  deviations through Quality System, engaging with all relevant personnel and
  functions as appropriate.
  
• Lead and actively participate in shift handovers.
  
• Liaise with Shift Lead regarding issues which may arise
  within the production area including highlighting of operational challenges.
  
• Use Lean Tools as part of daily operations (Standard
  Work, 5S, TPM, Gemba, Method 1,) to optimize efficiency and drive the culture
  of 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 with
  Company policies & SOPs & global regulatory guidelines (including
  cGMP/cGLP/cGCP), environmental guidelines, as appropriate.
  
• Support the development, commissioning &
  qualification of a new vaccines drug substance manufacturing equipment and
  subsequent transition to commercial manufacturing.
  

What skills you will need:

• Demonstrated experience in Bioprocessing, Upstream or
  Downstream.
  
• Knowledge and experience of relevant cGMP, safety, and
  environmental regulations within the biopharmaceutical industry.
  
• High level of adaptability working in a fast -paced
  environment and champion change.
  
• Experience with recording information in real time using
  electronic 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 environment
  is an advantage. 
  
• Excellent interpersonal skills, positive influence, team
  orientation, attention to detail, documentation skills, problem identification
  and problem -solving skills. 
  
• An ability to work independently, and as a member of a
  self - managed shift team in a dynamic, fast -paced environment that requires
  flexibility and initiative.
  

Shift Pattern: This position will initially
operate standard office hours Monday -Friday but will  be transition in Extended 7 -day shift pattern
with 12 -hour shifts, designed to provide 24/7 coverage using a 4 -week repeating
cycle. 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