...equipment.
Become involved in equipment/plant design to ensure that the equipment is fit for purpose, meets user, safety and GMP requirements and minimises life cycle cost.
Qualifications
Engineer shall possess a degree in Mechanical engineering, equivalent...
Within this role you will be responsible for working with cross-functional teams to drive activities that will ensure a state of continuous GMP compliance in Regeneron IOPS and to build inspection readiness capability across the organization. This role will help to build...
...tasks and projects related to management of Quality Assurance activities at Janssen Biologics as required by Good Manufacturing Practice (GMP). These activities include Incoming material release, Batch release, Change control, Event management, Supplier qualification, Annual...
Cpl Healthcare
Munster
2 days ago
...maintenance-based activities including Corrective / Preventative / Production Support / Calibrations / Electrical work, in accordance with site GMP (good manufacturing practices) and safety standards.
Mechanical fitter responsibilities to include maintenance and repair of...
Cpl Healthcare
Munster
3 days ago
...schedules & routines for new equipment in the facility.
Responsibilities:
Liaise with vendor to determine maintenance strategy for new GMP equipment.
SLA to be developed to suit business needs.
Develop preventative maintenance routine for new equipment.
Track and...
Tandem Project Management Ltd.
Munster
5 days ago
...working pattern can be considered for this role with a maximum of 2 days a week from home after the initial training period.
3+ years' GMP Pharma experience is required to apply for this role.
The purpose of this job is the data review of scientific test procedures used...
...Intermediates, Drug Substance & Drug Product in accordance with Analytical Standards and/or other approved protocols.
To comply with all GMP and analytical procedures relevant to area of work.
To adhere and comply with department High Performance Analytical Behaviours...
Life Science Recruitment
Munster
5 days ago
...Intermediates, Drug Substance & Drug Product in accordance with Analytical Standards and/or other approved protocols.
To comply with all GMP and analytical procedures relevant to area of work.
To adhere and comply with department High Performance Analytical Behaviours...
Orion Group
Munster
4 days ago
...contractors on approved supplier list in order to supplement full time employees; Submitting purchase requisitions as required
Ensuring that GMP and Regulatory requirements are complied with as evidenced by internal audits and inspections from Government Agencies
Directing,...
Regeneron Pharmaceuticals, Inc
Munster
1 day ago
...systems, electronic batch records, or manufacturing execution systems
Experience in a manufacturing environment
Experience in a GMP environment
Find working in an ambiguous environment with changing priorities exciting
Enjoy exploring technology and asking process...
Regeneron Pharmaceuticals, Inc
Munster
1 day ago
...compliance and improvement objectives.
Participate in assigned improvement projects.
To maintain accurate records in compliance with GMP expectations
To understand and internalise procedures relevant to GMP operations
Lab Systems Specialist
RK21122
Contract –...
Life Science Recruitment
Munster
2 days ago
...Oversees the preparation of project Basis of Design documents, Cost Estimates, and Schedules, ensuring alignment with safety, environmental, GMP, and financial requirements.
• Directs project detailed design, equipment specifications, and formulates project execution strategy....
Asset Recruitment
Munster
3 days ago
...Operations, the Site Training Lead and Site Stakeholders to ensure that the integrity of the training system is maintained and compliant with GMP (Good Manufacturing Practise) regulations.
This includes data entry, receiving and processing LMS change requests, troubleshooting...
Cpl Healthcare
Munster
2 days ago
...equivalent with 2+ years relevant administrative & data entry work experience to support responsibilities of position.
Experience in a GMP, SOP, ISO, or similar regulated environment strongly desirable.
PC literate with prior experience utilizing MS Word, Excel and other...
Regeneron Pharmaceuticals, Inc
Munster
1 day ago
...assisting with strategic planning for the Regeneron Industrial Operations and Product Supply (IOPS) Quality Auditing function. Quality (GMP) Auditing is responsible for maintaining the external audit program and performing external audits for Regeneron IOPS, with primary...
Regeneron Pharmaceuticals, Inc
Munster
4 days ago
...) a typical day might include, but it not limited to, the following:
Ensure that all work carried out is in compliance with current GMP, the required regulatory standards, conforms to company policies and standard operating procedures (SOPs).
Peer review data from other...
Regeneron Pharmaceuticals, Inc
Munster
5 days ago
..., protocols, reports, COAs, etc. generated to support commercial and development batches for accuracy, completeness, and compliance to GMP and procedural requirements.
Review of Standard Operation Procedures for manufacturing operations and cleaning.
Participate in any...
Cpl Healthcare
Munster
1 day ago
...changes.
Support equipment investigations to drive reliability and performance.
Ensure all areas of responsibility are compliance with GMP regulations.
Promotes and ensures safe working environment.
Coach and develop direct reports.
Works closely with Operations,...
Regeneron Pharmaceuticals, Inc
Munster
2 days ago
...supply chain, warehouse and/or logistics management.
Relevant experience may be substituted in lieu of educational requirement.
GMP compliance knowledge preferable.
Ability to define problems, collect and analyze data, establish facts, and draw valid conclusions....
Regeneron Pharmaceuticals, Inc
Munster
4 days ago
...external compliance requirements including data integrity requirements are incorporated into the lab systems and processes.
Monitoring of GMP and compendial compliance.
Own the GMP readiness plan for the labs to ensure a consistent and compliant approach across all...
Eli Lilly and Company
Munster
4 days ago
...creating, reviewing, approving, distributing, controlling and maintaining documentation to ensure effective and efficient application of GMP.
Documentation within this process includes, but is not limited to, manufacturing and packaging, laboratory, and general operations....
Regeneron Pharmaceuticals, Inc
Munster
1 day ago
...Professional experience
·Experience in computer troubleshooting or a similar technical field with Industrial IT work experience in a GMP manufacturing environment an advantage
·Familiarity with computer hardware, software, operations, and common problems.
·Proficient...
Kenny-Whelan & Associates
Munster
3 days ago
...raw material, utility, in process, release and stability testing of biotechnology products as required by Good Manufacturing Practice (GMP).
GENERAL SCOPE OF RESPONSIBILITIES:
• Achieves a high level of competency in laboratory methods and procedures to support raw material...
Cpl Healthcare
Munster
1 day ago
...includes audits if needed
Overseeing QC projects including analytical commitments for Regulatory filing, follow-up actions for general GMP inspections and its readiness
Tracking and coordinating major analytical investigations
Tracking and monitoring timeline of...
Regeneron Pharmaceuticals, Inc
Munster
4 days ago
...expected to begin in May and June and will last approximately three to four months.
Bringing in significant experience in pharmaceutical GMP settings, you will support a small permanent team with key qualification activities. Given, the size of the team, you will most...
Cork
17 days ago
£51.4k - £60k per annum
...appropriate field of study or equivalent work experience. You will also require the following:
*
5+ years of Automation Experience in a GMP environment
*
Automation PLC experience required in Siemens S7, Allen Bradley PLCs
*
Familiarity with other serialization...
Cork
11 days ago
£ 345 - 517 per day
...functional teams to execute validation deliverables.
Expertise in QC testing, laboratory processes, and experience within a pharmaceutical GMP compliant analytical lab.
Design, develop, and execute quality deliverables such as Validation Protocols, CSV Regulatory Risk...
Cork
25 days ago
...documentation, e.g., Design Spec, Configuration Spec, Testing, Security Plan, Test Summary Report, in accordance with site procedures and GMP guidelines
*
Review software release notes.
To apply for this CSV Engineer role, you will need a minimum of 3 years of experience...
Cork
11 days ago
...Intermediates, Drug Substance & Drug Product in accordance with Analytical Standards and/or other approved protocols.
* To comply with all GMP and analytical procedures relevant to area of work.
* To document all testing activities and to input results into computerised lab...
Tipperary Town, Co. Tipperary
19 days ago
...Execution of IOQ protocols for lab analytical instruments.
* Generation of risk assessments.
* Be a key SME for the AIQ process for all GMP audits
The Ideal Candidate
* A BSc in Engineering, Computer Science, or other technical degree
* 5+ years’ experience in a...
Cork
11 days ago