Manufacturing Biotech Associate Level 3

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 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 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