Manufacturing Biotech Associate O1
Manufacturing Biotech Associate O1
Posted on :
22-03-2025
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1 Vacancy
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Job Description
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 cloudbased 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 likeminded 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 diversecultural work setting.
This role will be part of Manufacturing work team/ Hub in our new state of the art single use multiproduct biotech facility in Dunboyne County Meath Ireland. The organizational structure at the site will be based on selfdirected work teams (SDWT) where decisions will be made at the level where the data exists.
The BTA is responsible for all procedures and processes associated with the manufacture of Drug Substance at Dunboyne manufacturing facility at the highest standards of Safety Quality and Compliance.
The BTA will be responsible for undertaking manufacturing operations involved in the production of biologic drug substance on their designated shift. Key responsibilities include the of an automated recipe using paperless technology in order to progress the drug substance through inoculation and cell culturing activities leading to filtration and purification of the product in a stateoftheart single use technology based facility. The incumbent will be involved in setting up the single use equipment between runs carrying out the production process according to world class GMP and EHS principles. The BTA will also be involved in driving to optimise and improve the processing activities through use of standard work and lean processing techniques while supporting operations team to consistently deliver on specific Key Performance Indicators (KPIs). 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 a concentrating on the engagement and development of self and peers.
Requirements
Primary responsibilities include but not limited to:
Biotech Associate level O1:
Support operations team to consistently deliver on specific Key Performance Indicators (KPIs) e.g.
Environmental Health and Safety (EHS) metrics Production Plan Overall Equipment Effectiveness
(OEE) compliance and team training.
Complete COMMIT cards to highlight ways of working within our SDWT s and Hubs and across our
site that support our COMMIT culture.
Provide immediate feedback to others at any time to reinforce good safety and improvement
behaviors and acts.
Execute commercial manufacturing processes according to established work instructions and
Standard Operating Procedures (SOPs).
Ensures that all assigned task related to manufacturing documentation support is in accordance with
good manufacturing practices.
Routinely talk about any safety issues you are concerned about.
Work as part of a dedicated process team where flexibility and teamwork are a key requirement.
Generate SOPs/ Work Instructions (WIs) to ensure compliance with regulatory standards.
Adhere to Right FirstTime principles.
Provide assistance and/or support maintenance engineering quality or other colleagues as
requested. Escalate issues as appropriate to manager/designee.
Maintain a high level of personal expertise and working knowledge of all aspects of the
manufacturing process and process equipment through continuous training and development.
Liaise with other groups and individuals to ensure planning of tasks is effective and linked into the
manufacturing process plan and site schedule.
Challenge and identify improvements to the safety and environmental programmes on site.
Celebrate with use of proactive recognition tools that inspire teams and individuals you collaborate with.
Take part in shift handovers and tier 1 meetings raising concerns or issues promptly and providing
options for resolutions.
Act as an ERT during emergency situation if trained. required.
Any other duties as and when assigned by the Manager.
General Competencies:
Bioprocess Associate level O1:
Demonstrate successes in a team environment in either a project or work related activities.
Demonstrate troubleshooting competency.
Desire to learn and develop.
Technical:
Bioprocess Associate level O1:
Understanding of Drug Substance Manufacturing Operations.
Understanding of GMP requirements in a Biopharmaceutical Facility.
Excellent communication skills and the ability to work in a cross functional collaborative environment.
Bioprocess Associate level O1:
Level 7 qualification in a science or engineering discipline or level 6 with a minimum of 1 3 years experience in a GMP Manufacturing environment or trade background. OR
Leaving Cert with relevant experience.
Startup experience in a largescale commercial drug substance facility or similar.
This role is a sitebased role.
This role will involve working shifts on a 4cycle 24/7 basis.
General Competencies: Bioprocess Associate level O1: Demonstrate successes in a team environment in either a project or work related activities. Demonstrate troubleshooting competency. Desire to learn and develop. Technical: Bioprocess Associate level O1: Understanding of Drug Substance Manufacturing Operations. Understanding of GMP requirements in a Biopharmaceutical Facility. Excellent communication skills and the ability to work in a cross functional collaborative environment. Bioprocess Associate level O1: Level 7 qualification in a science or engineering discipline, or level 6 with a minimum of 1 - 3 years experience in a GMP Manufacturing environment or trade background. OR Leaving Cert with relevant experience. Start-up experience in a large-scale commercial drug substance facility, or similar. This role is a site-based role. This role will involve working shifts, on a 4-cycle, 24/7 basis.
Employment Type
Full Time
Key Skills
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