...Your new company
Here in Hays we have a fantastic long-term opportunity for a Sterility Micro Analyst seeking to kickstart their career for our Scientific Services client to be based on their top of the range biopharmaceutical testing facility in the greater Waterford...
...are staffed by highly experienced and professional nursing recruitment consultants. We are now seeking a CSSD Technician Central Sterile Services Technician for a private hospital located in Dublin Ireland.
Responsibilities
~ All departmental equipment including...
...Associate Scientist (Manufacturing, Science & Technology), Sterile Drug Product page is loaded Associate Scientist (Manufacturing, Science & Technology), Sterile Drug Product
Apply locations Cruiserath - IE time type Full time posted on Posted 4 Days Ago job requisition...
Bristol-Myers Squibb
Fingal
1 day ago
...Associate Principal Scientist, Sterile Drug Product Commercialization - Ireland - Hybrid page is loaded Associate Principal Scientist, Sterile Drug Product Commercialization - Ireland - Hybrid
Apply remote type Hybrid locations IRL - Carlow - Carlow IRL - Tipperary - Ballydine...
MSD Malaysia
Ireland
9 hours ago
...Experience Required:
* Significant validation experience.
* Proficiency in IPQ, CQV, and PPQ methodologies.
* Prior experience in pharmaceutical manufacturing/production is essential.
* Steam sterilization experience.
* Bachelor's degree (Level 8) in Engineering Sciences
Westport, Co. Mayo
21 days ago
...inspections of batches, load set up, processing of Customer batches and completes all associated documentation.
Operates the VHP Sterilizer and conducts regular checks to verify conformance to specification and check alarms, taking appropriate action as needed.
At all...
...level of teamwork and engagement
~ Internal/external auditing experience would be an advantage
~ Validation experience including Sterilization, process and packaging validations would be beneficial
~ Knowledge of Medical Device manufacturing environment including cGMP...
...setting.
· A minimum 2 + Years in a maintenance and repair role within the Pharmaceutical Industry is preferred. Candidates with sterile fill finish, component preparation (i.e. Autoclaves, Washers, CIP skids) and high-speed inspection maintenance experience are desirable...
...5-7 years of experience working in an ISO certified environment required.
# Minimum of 2 years in a Quality leadership role
# Sterilization experience preferred
# Working knowledge of FDA QSR/ EUGMP regulations strongly preferred
Skills/Experience
# Excellent problem...
...patient care
contributes towards ward/department organisation
gives support to the operating theatre staff in the provision of sterile documented instruments and equipment for surgical procedures.
Qualifications/ Experience:
~ Must have experience working in a...
...HPRA, EMEA and other authorities related to Biologics and/or Pharmaceuticals.
Desirable:
Experience in direct interactions with regulatory agencies during site inspection.
Previous experience working in a sterile/low bioburden environment.
#LI-KV1...
€26.99k - €33.32k per annum
...Description:
We are seeking a skilled CSSD Technician to join our team in Dublin. The successful candidate will be responsible for the sterilization of medical equipment and supplies to ensure they are safe for use in medical procedures.
Key Duties and Responsibilities
Collect...
...comprehensive site services, bioreactors and fermenters, filtration and chromatography systems, prep and hold systems, and cleaning/sterilization systems.
Position Summary:
The Applications Specialist is a technical expert in biopharmaceutical clinical and...
€45k - €50k per annum
...product submission requirement.
~ Internal/external auditing experience would be an advantage.
~ Validation experience including Sterilization, process and packaging validations would be beneficial.
~ Knowledge of Medical Device manufacturing environment including cGMP...
...the NPI or postNPI phases.
Provide process development expertise for commercial drug product processing in specific areas such as sterile processing process characterization tech transfer and validation. Support commercial drug product manufacturing operations with...
...adherence to specifications.
Running of high-speed aseptic Filling lines – Isolator technology.
Aseptic assembly of Single Use Aseptic sterile systems.
Set-up of Sterile Filtration systems – pre & post filter integrity testing
Complete Visual Inspection on Finished...
€ 60 - 67 per hour
...including those of FDA, HPRA, EMEA and other authorities related to Biologics and/or Pharmaceuticals.
Desirable:
Experience in direct interactions with regulatory agencies during site inspection.
Previous experience working in a sterile/low bioburden environment....
...time to market, and maximize productivity. ABEC's products include process and equipment engineering/consulting services, comprehensive site services, bioreactors and fermenters, filtration and chromatography systems, prep and hold systems, and cleaning/sterilization systems
€60k - €65k per annum
...GMP setting.
A minimum 2 + Years in a maintenance and repair role within the Pharmaceutical Industry is preferred. Candidates with sterile fill finish, component preparation (i.e. Autoclaves, Washers, CIP skids) and high speed inspection maintenance experience are...
....
Experience with regulatory compliance in cGMP manufacturing and indepth knowledge of Eudralex Volume 4 Annex 1 Manufacture of Sterile Medicinal Products.
Proven ability to work in a high paced matrix organization and effectively influence change and escalate issues...
...~3rd level qualification in a Science/Engineering or related discipline and/or minimum 2 years GMP experience, preferably Aseptic/Sterile Manufacturing
~ Knowledge of working within a cGMP environment.
~ Experience working with SAP within a similar industry is preferable...
...of 4 years’ experience in an aseptic manufacturing environment.
Experience in aseptic techniques, formulation, aseptic filling of sterile products, and/or visual inspection of Parenteral products.
Detailed knowledge of cGMP and regulatory requirements in the pharmaceutical...
...production goals
Organize equipment flow, monitor clean and soiled hold times, appropriately label, and manage inventory of clean and sterilized equipment using Kanban systems to ensure quality control and track equipment expiration dates.
Required to comply with company's...
€75k - €90k per annum
...to ensure its ongoing compliance to the governing Quality and Regulatory Standards and its effectiveness in designing and developing sterile medical devices.
Management of the Quality System audit program both internally and external audits of critical subcontractors and...
...level qualification in Science/Engineering or related discipline
~2-3 Years working in a manufacturing environment, preferably Aseptic/Sterile Manufacturing.
~ Knowledge of Eyecare BU an advantage
~ Excellent communication skills
~ Ability to use sound judgment to make...
...and stability testing such as: Environmental Monitoring, Water sampling, Bioburden, Endotoxin, Growth promotion, In-process testing, Sterility testing, APET and Antibiotic Assay.
Report writing.
Draft and review documentation –SOPs, protocols, training modules,...
...Sterilisation Validation Engineer I on an initial 12-month contract. This is a hybrid role.
Responsibilities
Support routine Sterility Assurance activities e.g GMP, Standards Compliance, Cleanroom Risk Assessment, Limits review, Dose Audit activity, Cycle...
€ 25 - 32 per hour
...Endotoxin testing of water, in-process and drug product release samples
Bioburden testing of water & in-process drug product samples
Sterility testing
Water sampling
Lab Support duties such as Biological Indicator testing, Growth Promotion, Media Preparation,...
...facility fit studies, process safety and risk assessments for NPI.
Design, onboarding, and testing of single use assemblies for use in sterile manufacturing of ADC.
Process SME for equipment selection and C&Q activities for any new equipment.
Author scientific reports...
...required
~ Completion of quality records in QMS
~ Implementation of product dedicated controls for the Core 1 area.
~ Performing sterile filtration and filter integrity testing.
~ Supporting regulatory inspections as required
~
Qualifications
So, what...