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Downstream Bioprocess Associate -Shift

icon building Company : Psc Biotech
icon briefcase Job Type : Full Time

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Job Description - Downstream 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:

  • The Downstream Bioprocess Associate will play a key role
    in executing manufacturing operations for the production of biologic drug
    substances during assigned shifts. This position involves running automated
    recipes using paperless technology to guide the process from inoculation and
    cell culture through to filtration and purification, within a state -of -the -art
    facility utilizing single -use technologies.
  • The incumbent will be responsible for setting up and
    operating single -use equipment between production runs, ensuring all processes
    are executed in compliance with world -class GMP (Good Manufacturing Practices)
    and EHS (Environment, Health & Safety) standards.
  • In addition to core operational duties, the Downstream
    Bioprocess Associate will contribute to process optimization and continuous
    improvement initiatives, applying standard work and lean manufacturing
    principles to enhance efficiency and quality. The role also supports achieving
    team Key Performance Indicators (KPIs) and sustaining a culture of operational
    excellence.

  • This is a shift role.


Requirements

Responsibilities:

  • Support operations team in achieving Key Performance
    Indicators (KPIs) such as EHS metrics, Production Plan, OEE, compliance, and
    training.
  • Execute commercial manufacturing processes according to
    established work instructions and Standard Operating Procedures (SOPs).
  • Ensure all manufacturing documentation complies with Good
    Manufacturing Practices (GMP).
  • Maintain and update SOPs/Work Instructions (WIs) to align
    with regulatory standards and Right First -Time principles.
  • Participate in safety programs, report and discuss safety
    concerns, and promote a strong safety culture.
  • Take part in shift handovers and tier meetings,
    escalating issues promptly and suggesting resolutions.
  • Provide cross -functional support to maintenance,
    engineering, quality, and other departments as needed.
  • Engage in inspections, GEMBA walks, and Go -See activities
    to identify process improvements.
  • Utilize Lean and Six Sigma tools to drive continuous
    improvement, increase efficiency, and reduce waste.
  • Contribute to problem -solving and root cause analysis
    activities, applying past experience to determine effective solutions.
  • Maintain a high level of technical expertise and
    understanding of manufacturing processes and equipment through continuous
    learning.
  • Liaise with cross -functional teams to align manufacturing
    plans with overall site schedule and production goals.
  • Support and uphold EHS, GMP, and quality compliance at
    all times.
  • Participate as a trained Emergency Response Team (ERT)
    member during emergencies.
  • Mentor and train new team members on plant processes and
    safety practices.
  • Assist in audits and respond confidently to auditor
    queries during inspections or walkdowns.
  • Foster a collaborative and high -performance culture by
    recognizing and celebrating achievements.
  • Develop and manage production schedules based on
    equipment capacity, material availability, staffing, and demand forecasts.
  • Ensure production output, quality, and compliance meet
    organizational and regulatory expectations.
  • Execute preparatory and finishing production tasks in
    accordance with plans and procedures.
  • Operate independently under moderate supervision,
    demonstrating technical proficiency and accountability.

 

Experience & Skills Required:

  • 2 Years of Downstream processing experience.
  • Experience with GLIMS, SAP, and DeltaV
  • Preferred – operation of filtration, chromatography, and
    buffer preparation systems.

 



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