Dunboyne, Ireland | Posted on 04/24/2026
Industry Pharma/Biotech/Clinical Research
Work Experience 4-5 years
City Dunboyne
State/Province Meath
Country Ireland
Job Description
About PSC Biotech
Who are we?
PSC Biotech is a leading Biotech Consultancy firm founded in ****, 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 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 through learning & development in-house training mentorship through constant guidance to facilitate career progression.
We believe in creating high performance 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.
Purpose of Role:
The BTA is responsible for manufacturing operations involved in the production of biologic drug substance on their designated shift.
Key responsibilities include executing automated recipes using paperless technology to progress drug substance through inoculation and cell-culture activities, followed by filtration and purification in a state-of-the-art single-use technology facility.
The role includes setting up single-use equipment between runs and performing production activities in line with world-class GMP and EHS standards.
The BTA also drives optimisation and continuous improvement through standard work and lean processing techniques, supporting the operations team to consistently deliver key performance indicators (KPIs).
At all times, the role is focused on delivery to the patient by living the Dunboyne culture: a commitment to safety, right-first-time execution, and the engagement and development of self and peers.
Activities Within Role:
The BTA is responsible for procedures and processes associated with drug substance manufacture, delivering the highest standards of safety, quality and compliance.
Primary activities and responsibilities include:
Support and execution of end-to-end production operations
Operate equipment according to electronic batch records, sampling plans and standard operating procedures
Conduct all work activities with a strict adherence to the safety and compliance culture on site
Use lean Six Sigma tools to support continuous improvement (CI) projects that increase agility and flow, improve throughput, and reduce cycle time and inventory
Support the operations team to consistently deliver key performance indicators (KPIs), e.g., EHS metrics, production plan, overall equipment effectiveness (OEE), compliance and training
Ensure all assigned manufacturing documentation tasks are completed in accordance with GMP requirements
Work as part of a dedicated process team where flexibility and teamwork are key requirements
Create and update SOPs and work instructions (WIs) to ensure compliance with regulatory standards
Escalate issues to the manager/designee as appropriate
Maintain a high level of expertise and working knowledge of manufacturing processes and equipment through continuous training and development
Contribute to site safety and environmental programmes
Participate in shift handovers and tier meetings, raising concerns promptly and proposing options for resolution
Participate in internal audit programs and risk assessment compliance activity
Coach shift teams related to RFT documentation
Lead by example through coaching and mentoring
Coach CAPAs, change actions/ SOP updates, training module development/revision related to cell area
Troubleshoot and resolve issues and delays
Lead and participate in investigations arising from manufacturing documentation aspects when required
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 unit operation lead and be responsible for a unit operation
Requirements
Required Education, Experience and Skills:
Level 7 qualification in a science or engineering discipline desired
A level 6 with a minimum of 3+ years' experience in a GMP Manufacturing environment shall be deemed equivalent
High degree of problem-solving ability and adherence to scheduled timelines
A proven ability to lead cross functional teams and deliver on tight timelines
A proven ability to work with automated systems such as Manufacturing Execution System (MES), Systems Applications and Products (SAP), Delta V etc.
Experience with contamination control and batch release requirements
Experience with single-use technologies in a manufacturing environment
Experience of upstream and downstream unit operations for mAb manufacturing
This role involves shift work on a 24/7 basis
Preferred Experience and Skills
GMP manufacturing experience
Experience with systems such as SAP, Emerson Delta V and MES (PAS-X), and the use of automation in a manufacturing process
Reports to: Manufacturing Process Operations Shift Manager
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