Bioprocess Associate-Shift

Dundalk - Ireland

Monthly Salary: Not Disclosed

Experience Required: 1-3years

Posted on: 7 hours 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:

We are looking for a BioProcess Associate to join our Drug Substance team at our state-of-the-art fully integrated vaccine facility in Ireland. As a Bioprocessing Associate you will be a key member in our fast-growing dynamic startup-working with cutting-edge technology.

Requirements

Responsibilities:

Manufacturing processes include DS Downstream Processing (DSP) and Upstream Processing (USP) and Buffer / Media preparation
Carry out all production operations in the assigned area as per the relevant SOPs and Manufacturing Batch Records .
Assist in maintaining a safety orientated Culture cGMP compliant work environment at all times
Write review and revision of area Standard Operating Procedures (SOPs) On the Job Training (OJTs) Production Batch Records (PBRs) Logbooks Training Competencies and Work Instructions
Training and mentoring of colleagues in SOPs process execution and equipment operation.
Support Manufacturing team to consistently deliver on specific area Key Performance Indicators (KPIs) e.g. Safety Quality Schedule adherence Overall Equipment Effectiveness (OEE) and team training.
Assist with the investigation of and operations deviations through Quality System engaging with all relevant personnel and functions as appropriate.
Lead and actively participate in shift handovers.
Liaise with Shift Lead regarding issues which may arise within the production area including highlighting of operational challenges.
Use Lean Tools as part of daily operations (Standard Work 5S TPM Gemba Method 1) to optimize efficiency and drive the culture of Continuous Improvement (CI)
Support HAZOP and risk assessments as per requirements.
Provide assistance and/or support maintenance engineering quality or other colleagues as requested.
Conducts all activities that are in accordance with Company policies & SOPs & global regulatory guidelines (including cGMP/cGLP/cGCP) environmental guidelines as appropriate.
Support the development commissioning & qualification of a new vaccines drug substance manufacturing equipment and subsequent transition to commercial manufacturing.

What skills you will need:

Demonstrated experience in Bioprocessing Upstream or Downstream.
Knowledge and experience of relevant cGMP safety and environmental regulations within the biopharmaceutical industry.
High level of adaptability working in a fast-paced environment and champion change.
Experience with recording information in real time using electronic or manual systems.
Experience in executing operations while following SOPs Batch Records and Manufacturing Controls Systems.
Experience of working in Grade C D and CNC environment is an advantage.
Excellent interpersonal skills positive influence team orientation attention to detail documentation skills problem identification and problem-solving skills.
An ability to work independently and as a member of a self - managed shift team in a dynamic fast-paced environment that requires flexibility and initiative.

Shift Pattern: This position will initially operate standard office hours Monday-Friday but will be transition in Extended 7-day shift pattern with 12-hour shifts designed to provide 24/7 coverage using a 4-week repeating cycle. Two teams rotate through this schedule

Example :

Week 1: Work Monday Tuesday Friday Saturday Sunday (12-hour day shifts)Off Wednesday and Thursday

Week 2: Work Wednesday and Thursday only Off the other 5 days

Week 3: Same as Week 1: Work Monday Tuesday Friday Saturday Sunday

Week 4 Same as Week 2 :Work Wednesday and Thursday only

Required Skills:

Demonstrated experience in Bioprocessing Upstream or Downstream. Knowledge and experience of relevant cGMP safety and environmental regulations within the biopharmaceutical industry. High level of adaptability working in a fast-paced environment and champion change. Experience with recording information in real time using electronic or manual systems. Experience in executing operations while following SOPs Batch Records and Manufacturing Controls Systems.

Required Education:

Demonstrated experience in Bioprocessing Upstream or Downstream. Knowledge and experience of relevant cGMP safety and environmental regulations within the biopharmaceutical level of adaptability working in a fast-paced environment and champion with recording information in real time using electronic or manual systems. Experience in executing operations while following SOPs Batch Records and Manufacturing Controls Systems.

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...