As an Associate Process Data Scientist you will provide data and statistical support, to establish, organize and maintain effective data... ...continuous improvement of Regeneron’s Application of the In-Process Control (IPC) program
Accurately sourcing process data from paper...
...this role you will provide technical support on the manufacturing process and be a key member in the implementation of large-scale... ...Writing, reviewing, Standard Operating Procedures and other controlled documents as needed
Providing technical input to resolve process...
Process Sciences is a technical services department that deals with a range of scientific, technical, engineering and mathematical needs from the laboratory to the manufacturing floor. Process Sciences support the following areas Upstream Sciences, Downstream Sciences, Analytical...
Within this role you will support the Process Sciences Department with analysis, troubleshooting, and process validation of manufacturing... ...and/or technology transfer
Applying statistical process control tools in monitoring the manufacturing process
Investigating OOS...
As an Associate Process Scientist you would support the Process Sciences Department with analysis, troubleshooting, and process validation of manufacturing bioprocesses.
Note, this is a shift based position. It will involve extended days and evenings with occasional 24/...
Within this role you providing technical support for internal late stage and commercial manufacturing processes across sites, including engineering support for existing equipment and manufacturing processes. The Process Engineer will also support process transfers into Raheen...
...role you will be responsible for managing and overseeing Document Control and Archives operations. This includes oversight of the... ...with counterparts from sister sites to ensure global alignment of processes, systems and procedures, unified communication to user areas, and...
Within this role you will be responsible for supervising the laboratory quality control testing of a variety of raw materials, products, in-process materials, or stability samples in support of the company’s quality program.
As a Supervisor Quality Control within the HPLC...
As an Associate Process Scientist (Cell Banking) you would support the Process Sciences Department with analysis, troubleshooting, and process validation of manufacturing bioprocesses.
In this role a typical day might include, but is not limited to, the following:
Maintaining...
...validation, trending, and advancement of manufacturing and testing processes. To establish, organise and maintain effective statistics and... ...regression, difference and equivalency testing, design of experiments, control charts
You demonstrate an ability for designing and...
...Reconcile all data with inventory management system and manage stock control and inventory accuracy.
Logistics – plan, co-ordinate and... ...in all warehouse activities.
Support key tasks, projects, processes, procedures, and other relevant responsibilities as deemed necessary...
...training materials and EHS related procedures
Participating in process and system walk-downs and the completion of safety reviews with... ...; machinery; area; task specific; and making recommendations to control hazards
Developing, implementing and maintaining training...
...and Fill/Finish manufacturing operations, facilities and Quality Control laboratories to ensure a successful compliance profile.... ...reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may...
...and solving site electrical systems, PLC’s (Programmable Logic Controllers), PAT (Portable Appliance Testing) and carrying out assigned electrical... ...certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law...
...of all categories of laboratory Chemicals and Components Quality Control at the Limerick Manufacturing. Additionally, this position will... ...reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may...
...quality regulatory submission and approval.
* Reviews Change Controls by cross-checking the description in regulatory filings in INDs/... ...that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law...
...Ensuring that MES system installation aligns with site policies and processes
Coordinating the needs of functional groups across the site... ...and other changes to MES
Reviewing and approving MES Change Controls
Ensuring GxP compliance
Responding to audit inquiries...
...technical evaluations to demonstrate instrument suitability for change control documentation
Supervising engineering contractors... ...engineering preferred. Direct experience with biopharmaceutical process equipment is preferred.
#IRELIM #JOBSIEPR #LI-Onsite #REGNIRLTO...
...Provides Technical Writing assistance with the management of Change Controls, Deviations, CAPAs
Provides Technical Writing assistance with... ...reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you...
...coordination and completion of manufacturing deviations and change controls.
As an Associate / Compliance Specialist a typical day might... ...reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you...
...inclusive of but not limited to Manufacturing, Quality Systems, Quality Control, Quality Assurance, Facilities Maintenance, Engineering,... ...regulatory and customer audits.
May train personnel on quality system processes.
May supervise team members.
Perform additional duties as...
...Logbooks in accordance with cGMP standards
Monitoring production processes to obtain necessary data in support of investigations and track... ...all training in accordance with cGMP standards
May revise controlled documents (batch records, logbooks, SOPs, etc.) in accordance...
Summary: The Quality Compliance Coordinator supports data trending, process monitoring, and system administration activities to ensure... ...System (QMS). This position will focus on Deviation, CAPA, Change Control and Quality Risk Management elements of the QMS.
Essential Duties...
...be for you if:
You have the ability to work with automated control systems and with low voltages
You have the ability to loop check... ...You demonstrate an ability to occasionally work on other Process/Utility/Facility related work tasks/issues that are outside the...
...microbiological quality of products, manufacturing equipment, manufacturing process areas, and facility utilities.
Lead-Related Activities... ...calibration
Performing all duties relevant to the Quality Control Microbiology Analyst position as required
To be considered...
...industry best practices for cGMP across manufacturing, quality control, materials management, and validation.
As an Associate Director... ...not limited to, the following:
Overseeing QA Operations, processes and directing the activities of the QA Operations management team...
...specifying and commissioning new and renovated biopharmaceutical process equipment. You will be providing engineering support and problem... ...Designing and specifying cGMP process equipment, piping, and controls
Managing small-to-mid sized projects related to process equipment...
...Compliance Specialist will be responsible for managing QC's Change Controls/CAPAs and Workflows.
In this role a typical day might include... ...reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you...
...issues and appropriately communicating items to management, business process owner and users. Senior role would be the technical SME/Lead on... ...and enhancing the system
Processing IT Applications change control requests
Working with Validation and Quality departments...
...issues and appropriately communicates items to management, business process owner and users
Responsible for IT Applications documentation... .../Partner inspections
Processing IT Applications change control requests
Working with Validation and Quality departments to ensure...