Bioprocess Associate-Shift

PSC Biotech® Corporation; Dunboyne; On-site; EUR 35,000 - 55,000; Full time

Job summary

PSC Biotech seeks a Manufacturing Biotech Associate for our state-of-the-art single-use multiproduct facility in Ireland. You will join a self-directed shift team to deliver batch operations, perform setup, operation, cleaning, validation, in-process testing, and use paperless systems to generate drug substance.

You must have a science qualification and 0–3 years in biotech/pharma, with the ability to work days, nights and weekends in rotation.

Qualifications

• Science qualification in a technical, engineering or science-based discipline or equivalent.
• 0 to 3 years’ experience in biotechnology/pharma or equivalent.
• Experience in a highly regulated pharmaceutical manufacturing environment.
• Understanding of biologic drug substance production is advantageous.
• Ability to work in a shift team and on own initiative.

Responsibilities

• Production of biologic drug substance on shift team; prepare, operate and monitor equipment and perform cleaning and validation.
• Progress an automated recipe using paperless technology to generate drug substance via inoculation and cell culture.
• Set up single-use equipment between runs and ensure GMP/EHS standards are followed.

Skills

Biotech manufacturing

GMP compliance

Quality mindset

Education

Science qualification

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.

About PSC Biotech

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

Job Description

• A fantastic and exciting opportunity has arisen for a Manufacturing Biotech Associate ,our new state of the Art single use Multiproduct Biotech facility.
• The Manufacturing BioTech Associate will work in a manufacturing self-directed shift team to deliver batch operations successfully, identify and resolve issues in order to allow the site to deliver for our patients in a culture that supports Quality, EHS, Learning and Continuous improvement.
• Ability to work 24/5 shift operations, which include days, nights and weekend work in rotation if required.

What you will do:

• The production of biologic drug substance on their designated shift team and will be responsible for the preparation, operation and monitoring of equipment, use of business systems and carrying out tasks including but not limited to the cleaning, validation, in-process testing.
• The progression of an automated recipe using paperless technology in order to generate the drug substance through inoculation and cell culturing activities directing to filtration and purification of the product.
• Setting up the single use equipment between runs, carrying out the production process according to world class GMP and EHS standards and driving to optimise and improve the processing activities through use of standard work and lean processing techniques.
• Focusing 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.

Work Experience

• A science qualification in a technical, engineering or science-based discipline or equivalent.
• 0 to 3 years’ experience in the biotechnology and/or pharmaceutical industry or equivalent.
• Experience in a highly regulated pharmaceutical manufacturing environment
• Good understanding in the production of biologic drug substance and experience an advantage.
• Ability to work as part of a shift team and on own initiative in a constructive manner.
• Ability to think logically and be proactive under pressure.
• Flexible and self-motivated