Process Specialist

1 week ago

Dublin, Dublin City, Ireland PSC Biotech Corporation Full time

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 points 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 to 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 through 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:

This role will be part of the Manufacturing Self Directed Work Team/ Hub in our new state-of-the-art single-use multi-product biotech facility. The organisational structure at the site will be based on self-directed work teams (SDWT) where decisions will be made at the level where the data exists.

The BTA is responsible for all procedures and processes associated with the manufacture of Drug Substance at the manufacturing facility, at the highest standards of Safety, Quality and Compliance.

The BTA will be responsible for undertaking manufacturing operations involved in the production of biologic drug substance on their designated shift. Key responsibilities include the execution of an automated recipe using paperless technology in order to progress the drug substance through inoculation and cell culturing activities, leading to filtration and purification of the product in a state-of-the-art single-use technology based facility. The incumbent will be involved in setting up the single-use equipment between runs, carrying out the production process according to world-class GMP and EHS principles. The BTA will also be involved in driving to optimise and improve the processing activities through the use of standard work and lean processing techniques while supporting the operations team to consistently deliver on specific Key Performance Indicators (KPIs). At all times this role is focused on delivery to the patient through living the culture including a commitment to safety, focusing on right first time in everything we do and concentrating on the engagement and development of self and peers.

This role is a site-based role.

This role will involve working shifts, on a 24/7 basis.

Requirements

Responsibilities:

  • Participate in internal audit programs and risk assessment compliance activity.
  • Implement CAPAs and Change actions/SOP updates, training module development/revision related to the cell area.
  • Coach shift teams related to RFT documentation.
  • Lead by example through coaching and mentoring on Production systems skill transfer.
  • Utilise real-time data analytics for making decisions on value stream improvement initiatives.
  • Troubleshoot and resolve issues and delays.
  • Lead and participate in investigations arising from manufacturing documentation aspects when required.
  • Promote EHS leadership behaviours and engage employees at all levels on EHS issues.
  • Promote an environment where everyone speaks up for our culture of safety and looks out for one another.
  • Confirm that all activities have been correctly completed by the end of shift such as Real-time batch record/SAP Comet review and e-logs review.
  • Be a visible leader of safety initiatives and stay actively involved in safety forums.
  • Act as a Cell Lead and be responsible for a unit operation.
  • Any other duties as assigned by the Manager.

Skills & Education:

  • Ability to interact with multiple stakeholders across numerous departments.
  • Excellent communication skills.
  • Ability to manage multiple priorities and know when to escalate issues for resolution.
  • Excellent troubleshooting skills as well as an ability to coach and mentor self-directed teams through complex problem solving.
  • Level 7 qualification in a science or engineering discipline, or Level 6 with a minimum of 1-3 years' experience in a GMP regulated manufacturing environment.
  • Experience of Upstream/Downstream Processing.
  • Experience in a highly regulated pharmaceutical manufacturing environment would be desirable.
  • Proven record of accomplishments in a regulated industry.
  • Start-up experience in a large-scale commercial drug substance facility, or similar.
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