Process Engineer

About PSC Biotech

Who we are?
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.

Overview:

This role will be part of the Manufacturing Self Directed work team/ Hub in our new state of the art single use multi-product biotech facility in County Meath, Ireland. The organisational structure at the site will be based on self-directed work teams where decisions will be made at the level where the data exists.

This role will work across the site self-directed work teams and hub teams to identify and resolve issues in order to allow the site to achieve our Governance Pillars in People, Safety, Quality, Delivery and Cost.

Will work with a team of Manufacturing Specialists and play a key role in supporting the site in Engineering and PPQ batch campaigns. Support MFG Days lead with interviewing and hiring and will help manage intern roles.

They will look to drive continuous improvements and will be a key stakeholder at enterprise meetings and act as a designee for the MFG Days Lead.

Responsibilities:

This role will deliver key metrics such as

Compliance Excellence Deviation Management, Change Management and QMS Integration

EHS Event Investigation

GMP Readiness

Audit preparation

Problem Solving and Root Cause Analysis

Next Product Introductions

Technical Support and Troubleshooting for Upstream and Downstream Processing

Trend Identification and Issue Resolution

Project Management

At all times this role is focused on delivery to the patient through living the Dunboyne 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.

Requirements

Qualifications and Experience:

The successful candidate will have 5 years experience in a GMP regulated environment with strong technical knowledge of upstream and downstream processing.

They will be familiar with MES, Delta V and electronic batch records.

They will have strong technical writing skills and be proficient in the following areas Documentation Management, Change Management, Deviation Management.

Proven track record of utilising data to drive issue resolution and decision making.

Strong stakeholder management skills are desirable.