Manufacturing Bioprocess Associate

PSC Biotech® Corporation; Dunboyne; On-site; EUR 55,000 - 75,000; Full time

Job summary

PSC Biotech is seeking a Senior Manufacturing Bioprocess Associate to support end-to-end production operations for Fed Batch and Continuous Manufacturing at our Dunboyne, Ireland facility.

The role requires GMP manufacturing experience, troubleshooting skills, and the ability to work independently within a cross-functional team while maintaining safety and compliance on site. Some weekend/out-of-hours work may be required.

Qualifications

• Level 7 qualification in science or engineering is preferred.
• Level 6 with 3+ years GMP manufacturing experience is acceptable.
• Strong troubleshooting and problem-solving abilities are required.

Responsibilities

• Will support end-to-end production operations for Fed Batch and Continuous Manufacturing.
• Operate equipment according to electronic batch records, sampling plans, and SOPs.
• Able to troubleshoot problems and continuously learn and improve processes.
• Support weekend or out-of-hours work to back manufacturing activities.
• Conduct all work with strict adherence to safety and compliance on site.
• Assist in authoring electronic batch records and work instructions.

Skills

Troubleshooting

Problem-solving

Teamwork

Independence

Safety and compliance

Education

Level 7 qualification in science or engineering

Level 6 with 3+ years GMP manufacturing experience

Tools

Emerson DeltaV

PAS X

Job description

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.

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.

The facility is designed to be operated in a multi-product mode which requires flexibility to adjust as the pipeline of clinical and commercial biologics-based medicines demands change.

The Senior Manufacturing Bioprocess Associate will provide operational support for shop floor operations of the Late Stage and Launch Pipeline at our new state of the art single use biotechnology facility in Dunboyne, Ireland.

The client serves as a magnetic force that attracts, recognizes, and integrates people of diverse backgrounds and perspectives.

Essential Functions and Responsibilities (Includes, but are not limited to)

• Will support end-to end production operations for both Fed Batch and Continuous Manufacturing.
• Operate equipment according to electronic batch records, sampling plans and standard operating procedures.
• Ability to solve problems with a desire to continuously learn, improve and develop.
• Support weekend or out of hours work on select frames to support manufacturing activities.
• Conduct all work activities with a strict adherence to the safety and compliance culture on site.
• Supporting the Authoring of electronic batch records, sampling plans, work instructions and standard operating procedures.

The Senior Manufacturing Bioprocess Associate is also responsible for:

• Work as part of a dedicated process team where flexibility and teamwork are a key requirement.

Requirements

• Level 7 qualification in a science or engineering discipline desired.
• A level 6 with a minimum of 3+ years’ experience in a GMP Manufacturing enviornment shall be deemed equivalent.
• Competent in troubleshooting and show practical problem-solving capabilities.
• Ability to work independently and within a cross-functional team.
• Familiarity with contamination control and batch release requirements.
• Understanding of Upstream and Downstream Unit Operations for mAb manufacturing.
• Understanding of both continuous and batch fed manufacturing processes.
• Experience with Emerson DeltaV, Pas X, and the use of Automation in a manufacturing Process.
• Experience in various Single-Use techniques and experiences in the area of an end to end Single Use facility.
• Commissioning and Qualification experience.
• This role is a site based role.
• This role may require flexible work arrangements.