Manufacturing Biotech Associate

Dunboyne - Ireland

Monthly Salary: Not Disclosed

Experience Required: 1-3years

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

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 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 clients 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:

As a Manufacturing Biotech Associate you will be part of a self-directed work team in Downstream Operations responsible for all procedures and processes associated with the manufacture of Drug Substance. The Manufacturing Biotech Associate leads by example by always upholding the highest standards of Safety Quality GMP Right First Time and Compliance.

Key responsibilities include the execution of an automated recipe using paperless technology to progress the drug substance through inoculation and cell culturing activities leading to filtration and purification of the product in a single use technology-based facility.

The Biotech Associate will also be involved in optimising and improving processing activities through use of standard work and lean processing techniques while consistently delivering on specific KPIs.

Requirements

Responsibilities:

Be strong technically with an excellent ability to grasp processes and procedures. Aspiring to be an SME across the Downstream business unit be strongly motivated to acquire knowledge and understand all Downstream processes to a micro level
Be approachable supportive inclusive to other team members while striving to work in a cohesive and proactive team with a never let a teammate fail mindset
Display flexibility adaptability innovation with an ability to think on your feet also possess a strong skill set for logical root cause analysis and problem solving
Be an excellent communicator and true team player with concern for others
Be able to deliver business unit goals through close collaboration with their team members but also with colleagues across other departments
Display high initiative daily seeks the production schedule and helps lay plans to achieve it
Takes part in shift handovers and Tier meetings raising any concerns or issues promptly and providing options for resolutions.
Be actively involved by participating in inspections GEMBAs and Go-Sees improvement projects and other initiatives
Perform documentation tasks as authorised and any other administrative tasks as directed by your manager
Aspire to become proficient with production systems such as MES DeltaV SAP GLIMS PROCAL and others
Deputised if required to represent the department at meetings and discussions and performs any other duties as appropriate when assigned by the Manager

What skills you will need:

A Level 7 or higher qualification in a science engineering or technical discipline
Experience in a GMP or regulated manufacturing or business environment a definite advantage
Excellent communication skills and the ability to work in a cross functional collaborative team
Be able to demonstrate research or knowledge of the overall Upstream and Downstream processes and in particular Downstream processes
Good PC skills with an ability to work with automated business or manufacturing systems
Knowledge and understanding of GMP and quality systems
Troubleshooting and problem-solving competency
Desire to learn and develop. Ability to interact with multiple stakeholders across numerous departments
Knowledge and experience of Kanban JIT 5S and Lean Manufacturing methodologies would be an advantage
Ability to manage multiple priorities and know when to escalate issues for resolution.
A proven ability to deliver on tight timelines

Shift Pattern: Willingness and ability to work 24/7 shift operations which include 12-hour shifts of days nights and weekend work in rotation

Required Skills:

Shift Pattern: Willingness and ability to work 24/7 shift operations which include 12-hour shifts of days nights and weekend work in rotation A Level 7 or higher qualification in a science engineering or technical discipline Aspiring to be an SME across the Downstream business unit be strongly motivated to acquire knowledge and understand all Downstream processes to a micro level

Required Education:

Shift Pattern: Willingness and ability to work 24/7 shift operations which include 12-hour shifts of days nights and weekend work in rotationA Level 7 or higher qualification in a science engineering or technical disciplineAspiring to be an SME across the Downstream business unit be strongly motivated to acquire knowledge and understand all Downstream processes to a micro level

About PSC Biotech Who are wePSC 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 solutio...