Within a manufacturing function you will be performing tasks supporting the manufacturing operations of both clinical and commercial manufacturing... ...of the Manufacturing team to carry out tasks in line with the production schedule as directed by Team Leads and Supervisors
Ensuring...
Within this role you will be responsible for the commercial manufacturing compliance requirements, supervising the compliance team in relation... ...scale manufacturing compliance aspect of recombinant proteins production to approved protocols, regulation, and schedule.
Supervises...
...this role will manage the day-based support requirements of the manufacturing operations team. Provide direction and troubleshooting... ...This is a extended days shift position. As a Manager Biotech Production (Downstream Operations) a typical day may include, but are not...
...will strategically manage business relationships and facilitate day-to-day operations with Contract Manufacturing Organizations (CMOs) and Partners through the Drug Product (DP) Manufacturing Team to achieve a consistently high level of interaction in order to meet or exceed...
...Department with analysis, troubleshooting, and process validation of manufacturing bioprocesses.
As a Associate Process Scientist, a typical... ...Authors Process Validation protocols and report
Performs product impact assessments
Investigates OOS and OOL IPCs
Data mining...
Within this role you will be working as part of the Manufacturing Team to carry out tasks in line with the production schedule as directed by Team Leads and Supervisors.
As an Associate Biotech Production Specialist, a typical shift might include, but is not limited to,...
Within this role you will be responsible for the commercial Manufacturing Documentation team. Facilitate and coordinate Manufacturing records review to meet batch disposition timelines, preparation and review of Cleaning Verification Packs, PRIMR data entry and management of...
The Production Maintenance Supervisor oversees the operations of the process area maintenance functions at the IOPS Ireland Manufacturing Plant.
A typical day might include, but is not limited to, the following:
Supervising a group of employees or outside contractors...
In this role you will be responsible for providing QA oversight and support to manufacturing activities. Performing and leading activities in support of dispositioning product while ensuring compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Regeneron...
...this role you will be responsible for the administration, configuration, implementation, maintenance and ongoing support of various Manufacturing equipment specific applications and Systems in a cGMP environment.
As an Automation Engineer, a typical day might include, but...
...setting expectations amongst key stakeholders, react to and resolve product supply issues and have a strong customer focus is a key... ...and external batches.
Works with key internal stakeholders (Manufacturing, QA, QC, etc) to ensure successful process execution and delivery...
Within this role you will be responsible for providing technical support on the manufacturing process. You will be a key member in the implementation of large scale commercial manufacturing production program and heavily involved in technical transfer of processes.
This is a...
...role you will be responsible for performing testing to ensure cGMP compliance in the manufacturing facility. You would also be responsible for assessing the microbiological quality of products, manufacturing equipment, manufacturing process areas, and facility utilities....
...Department with analysis, troubleshooting, and process validation of manufacturing bioprocesses.
Note, this is a shift based position. It will... ...Process Validation protocols and report
Performing product impact assessments
Data mining and retrieval for colleagues...
...providing expertise and leadership in the Quality function. Responsible to ensure that licensed product is certified and released to market in compliance with commercial manufacturing license and clinical (IMP) products in accordance with EU directive 2001/83/EC, 2004/94/EC...
...team and is a key leader in the cross functional support of the manufacturing activities. This role will proactively identify and implement... ...batch review activities to support batch disposition of Regeneron Products
Overseeing Ireland Document Control (DC) operations and...
...strategic planning for the Regeneron Industrial Operations and Product Supply (IOPS) Quality Auditing function. Quality (GMP) Auditing... ...and warning letters.
Collaborates with Procurement, External Manufacturing, Drug Product Quality, QA & Operations and other team members...
As a QC Micro Analyst you would perform testing to ensure cGMP compliance in the manufacturing facility. Responsible for assessing the microbiological quality of products, manufacturing equipment, manufacturing process areas, and facility utilities.
Note, this is a shift...
...and/or Certificate of Analysis
Examining, stocking, and distributing materials in inventory and to manufacturing
Filling requisitions and dispensing items to production workers manually and electronically
Generating labels and applying labels to received inventory...
...development of analytic solutions that support Industrial Operations and Product Supply (IOPS). The analyst will work with the business to... ..., but is not limited to, the following:
Work closely with Manufacturing, Supply Chain, Quality Control, Quality Assurance, IT, and...
...ownership for providing floor support during operations of off-site manufacturing. This role is responsible for reviewing process data to ensure... ...to, the following:
Providing process knowledge for new product introduction, technology transfer, process troubleshooting and...
...qualification activities and data integrity initiatives in regard to small manufacturing and laboratory equipment (e.g. HPLC/UPLC, TOC analyser, FTIR, microscopes) in the frame of Industrial Operations and Product Supply of biological products in accordance with cGxP, regulatory...
...laboratory quality control testing of a variety of raw materials, products, in-process materials, or stability samples in support of the... ...not limited to, the following:
Coordinating with members of Manufacturing, R & D, and Formulation to provide analytical support...
...functional meetings and providing guidance and consultation to change control owners
Meeting with External Manufacturing to discuss changes for applicable products
Maintaining internal databases and tracking of partner notifications
Developing, monitoring, and...
...peak load and processing activity to ensuring Maintenance and production activities are met
As a Lead Utilities Maintenance Technician... ...operation of equipment and systems
Following current good manufacturing practices (cGMPs) and good business practices (G)
To be...
...medical device, food or dairy industry or even be working in the manufacturing industry in a cleanroom environment.
Are you familiar with... ...talk to us!
At our state-of-the-art Industrial Operations and Product Supply (IOPS) facility in Raheen, Limerick our dedicated team...
...flexible, innovative, cost effective, compliant and quality-focused manufacturing of Biopharmaceuticals.
As an Automation Infrastructure... ...the smooth transition of projects from Development into Production Environment
Overseeing migration of data from legacy systems...
...the functional areas to ensure high-quality, safe, and effective products that are compliant with global regulatory expectations with... ...is required. Knowledge and experience in supporting biological manufacturing sites and laboratories is preferred. Experience should also include...
...experience and 3-5+ years of experience working in an EHS role preferably within the pharmaceutical industry or other similar regulated manufacturing industry. A thorough knowledge of EHS legislation for a facility operating within Ireland/Europe is required. Experience in...
...responsible for promoting the use of statistical thinking across the site departments to support validation, trending, and advancement of manufacturing and testing processes. Within this role you would establish, organise and maintain effective statistics and data evaluation...