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Validation Lead at Katalyst Healthcares Life Sciences
Raritan, NJ 08869, USA - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Experience Required
Minimum 3 year(s)
Validation Engineer at Katalyst Healthcares Life Sciences
Summit, NJ 07901, USA - Full Time
Skills Needed
Documentation Practices, Pharmaceutical Industry, Equipment Qualification, Outlook, Server Technologies, Computer Science, Instrumentation, Manufacturing Systems, Vendors, Excel, Contractors, Computer Skills, Compliance Regulations, Communication Skills, Audit Trail
Specialization
Computer Science, Engineering
Qualification
BSc
Experience Required
Minimum 5 year(s)
USA-Process Engineer III (Engineering) at Katalyst Healthcares Life Sciences
Morristown, NJ 07960, USA - Full Time
Skills Needed
Troubleshooting, Presentations, Project Teams, Project Management Skills, Manufacturing Processes, Cfr, Suppliers, Analytical Skills, Iata, Ista, Soft Skills, Technical Discussions, Root
Specialization
Engineering
Qualification
Graduate
Senior Statistical Programmer at Katalyst Healthcares Life Sciences
Worcester, MA 01601, USA - Full Time
Skills Needed
Pharmaceutical Industry, R, Statistics, Interpersonal Skills, Communication Skills, Sas Programming, Computer Science, Reporting Requirements
Specialization
Computer Science, Statistics, Math
Qualification
Graduate
Occupational Therapist Assistant at San Jose Healthcare Wellness Center
San Jose, CA 95112, USA - Full Time
Skills Needed
Communication Skills, Geriatric Rehabilitation, Occupational Therapy, Progress Notes, Medical Terminology
Qualification
Graduate
Clinical SAS Programmer at Katalyst Healthcares Life Sciences
Cambridge, Massachusetts, USA - Full Time
Skills Needed
Validation, Statistical Programming, Figures, Sas Programming, Sdtm, Communication Skills, Regulatory Agencies, Regulatory Guidelines, Reporting Requirements, Therapeutic Areas
Qualification
Graduate
Medical Radiation Technologist at Haliburton Highlands Health Services
Haliburton, ON, Canada - Full Time
Skills Needed
Mobile Equipment, Addition, Management Skills
Specialization
Maintain current bcls certificate
Qualification
Trade Certificate
Experience Required
Minimum 2 year(s)
Senior Statistical Programmer at Katalyst Healthcares Life Sciences
Milwaukee, WI 53201, USA - Full Time
Skills Needed
Mathematics, Computer Science, Cdisc Standards, Addition, Software, Python, R, Statistics, Spotfire
Specialization
Statistics mathematics computer science or a related field required
Qualification
Graduate
Spinal Outpatient Physiotherapy Team Leader at Frimley Health NHS Foundation Trust
Fleet GU51 4LZ, England, United Kingdom - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
CSV Analytical and Enterprise Validation Specialist IV at Katalyst Healthcares Life Sciences
Portsmouth, NH 03801, USA - Full Time
Skills Needed
Good Communication Skills
Specialization
The field
Qualification
BSc
Experience Required
Minimum 5 year(s)
Nuclear Medicine and DXA Support Worker at Swansea Bay University Health Board
Swansea SA2 8QA, Cymru / Wales, United Kingdom - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Staff Nurse at Frimley Health NHS Foundation Trust
Windsor SL4 3DP, England, United Kingdom - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Staff Nurse at Frimley Health NHS Foundation Trust
Frimley GU16, England, United Kingdom - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Staff Nurse at Frimley Health NHS Foundation Trust
Slough SL2 4HL, , United Kingdom - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Manager, Business Sustainability at Western Sydney Local Health District
Westmead, New South Wales, Australia - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Senior Clinical Data Analyst at Katalyst Healthcares Life Sciences
Boston, MA 02108, USA - Full Time
Skills Needed
Transformation, Sas, Healthcare Industry, Data Analysis, Power Bi, Python, Data Quality, Regression Analysis, Sql, R, Data Visualization, Presentation Skills, Analytical Techniques, Tableau, Analytics, Biostatistics
Specialization
Engineering, Relevant Field
Qualification
Graduate
Experience Required
Minimum 3 year(s)
Quality Engineer – II at Katalyst Healthcares Life Sciences
Moorpark, California, USA - Full Time
Skills Needed
Fishbone, Microsoft Office, Root, Iso
Specialization
Engineering quality or a related technical field
Qualification
Graduate
Experience Required
Minimum 1 year(s)
Senior Occupational Therapist at Western Sydney Local Health District
Blacktown, New South Wales, Australia - Full Time
Skills Needed
Occupational Therapy, Patient Outcomes
Qualification
Graduate
Quality Engineer II at Katalyst Healthcares Life Sciences
Irvine, CA 92602, USA - Full Time
Skills Needed
Post Market Surveillance, Facilitation, Technical Writing, Psur, Manufacturing Processes
Specialization
A related life science/technical/engineering discipline or equivalent preferred
Qualification
Graduate
Experience Required
Minimum 5 year(s)
Level 1/2 Occupational Therapist at Western Sydney Local Health District
Westmead, New South Wales, Australia - Full Time
Skills Needed
Discharge Planning, Medical Records, Patient Care, Clinical Documentation
Qualification
Graduate
Validation Lead at Katalyst Healthcares Life Sciences
Raritan, NJ 08869, USA -
Full Time


Start Date

Immediate

Expiry Date

11 Sep, 25

Salary

0.0

Posted On

12 Jun, 25

Experience

3 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Good communication skills

Industry

Information Technology/IT

Description

Roles & Responsibilities:

  • Minimum 3+ years’ experience with SAP or Blue Yonder Warehouse Management Systems.
  • 3+ years’ experience with System Development Lifecycle.
  • 3+ years’ experience in Computer System Validation.
  • Experience with FDA CSA principles Experience with J&J CSV Framework Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation.
  • Knowledge of FDA guidance and industry standards (i.e., GAMP) Experience in writing and executing documentation for all aspects of the validation deliverables (etc. Requirements, Compliance/validation Plans, test protocols, Test Summary reports and Compliance/Validation Reports.
  • Experience in reviewing system test and user acceptance test scripts, Traceability matrix and Design Specs. Experience in QA Methodologies, designing, reviewing and approving Test Plans, systems and UAT test scripts and Test procedures.
  • Strong verbal and written communication skills.
  • Ability to work as a team player, lead a team or accomplish tasks without supervision.
  • Ability to work with remote teams and support several changes/projects simultaneously.
  • Ability to provide Validation guidance, timely reviews, and escalations to TQ management.
Responsibilities
  • Minimum 3+ years’ experience with SAP or Blue Yonder Warehouse Management Systems.
  • 3+ years’ experience with System Development Lifecycle.
  • 3+ years’ experience in Computer System Validation.
  • Experience with FDA CSA principles Experience with J&J CSV Framework Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation.
  • Knowledge of FDA guidance and industry standards (i.e., GAMP) Experience in writing and executing documentation for all aspects of the validation deliverables (etc. Requirements, Compliance/validation Plans, test protocols, Test Summary reports and Compliance/Validation Reports.
  • Experience in reviewing system test and user acceptance test scripts, Traceability matrix and Design Specs. Experience in QA Methodologies, designing, reviewing and approving Test Plans, systems and UAT test scripts and Test procedures.
  • Strong verbal and written communication skills.
  • Ability to work as a team player, lead a team or accomplish tasks without supervision.
  • Ability to work with remote teams and support several changes/projects simultaneously.
  • Ability to provide Validation guidance, timely reviews, and escalations to TQ management
Validation Lead at Katalyst Healthcares Life Sciences
Raritan, NJ 08869, USA - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Experience Required
Minimum 3 year(s)
Validation Engineer at Katalyst Healthcares Life Sciences
Summit, NJ 07901, USA - Full Time
Skills Needed
Documentation Practices, Pharmaceutical Industry, Equipment Qualification, Outlook, Server Technologies, Computer Science, Instrumentation, Manufacturing Systems, Vendors, Excel, Contractors, Computer Skills, Compliance Regulations, Communication Skills, Audit Trail
Specialization
Computer Science, Engineering
Qualification
BSc
Experience Required
Minimum 5 year(s)
USA-Process Engineer III (Engineering) at Katalyst Healthcares Life Sciences
Morristown, NJ 07960, USA - Full Time
Skills Needed
Troubleshooting, Presentations, Project Teams, Project Management Skills, Manufacturing Processes, Cfr, Suppliers, Analytical Skills, Iata, Ista, Soft Skills, Technical Discussions, Root
Specialization
Engineering
Qualification
Graduate
Senior Statistical Programmer at Katalyst Healthcares Life Sciences
Worcester, MA 01601, USA - Full Time
Skills Needed
Pharmaceutical Industry, R, Statistics, Interpersonal Skills, Communication Skills, Sas Programming, Computer Science, Reporting Requirements
Specialization
Computer Science, Statistics, Math
Qualification
Graduate
Occupational Therapist Assistant at San Jose Healthcare Wellness Center
San Jose, CA 95112, USA - Full Time
Skills Needed
Communication Skills, Geriatric Rehabilitation, Occupational Therapy, Progress Notes, Medical Terminology
Qualification
Graduate
Clinical SAS Programmer at Katalyst Healthcares Life Sciences
Cambridge, Massachusetts, USA - Full Time
Skills Needed
Validation, Statistical Programming, Figures, Sas Programming, Sdtm, Communication Skills, Regulatory Agencies, Regulatory Guidelines, Reporting Requirements, Therapeutic Areas
Qualification
Graduate
Medical Radiation Technologist at Haliburton Highlands Health Services
Haliburton, ON, Canada - Full Time
Skills Needed
Mobile Equipment, Addition, Management Skills
Specialization
Maintain current bcls certificate
Qualification
Trade Certificate
Experience Required
Minimum 2 year(s)
Senior Statistical Programmer at Katalyst Healthcares Life Sciences
Milwaukee, WI 53201, USA - Full Time
Skills Needed
Mathematics, Computer Science, Cdisc Standards, Addition, Software, Python, R, Statistics, Spotfire
Specialization
Statistics mathematics computer science or a related field required
Qualification
Graduate
Spinal Outpatient Physiotherapy Team Leader at Frimley Health NHS Foundation Trust
Fleet GU51 4LZ, England, United Kingdom - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
CSV Analytical and Enterprise Validation Specialist IV at Katalyst Healthcares Life Sciences
Portsmouth, NH 03801, USA - Full Time
Skills Needed
Good Communication Skills
Specialization
The field
Qualification
BSc
Experience Required
Minimum 5 year(s)
Nuclear Medicine and DXA Support Worker at Swansea Bay University Health Board
Swansea SA2 8QA, Cymru / Wales, United Kingdom - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Staff Nurse at Frimley Health NHS Foundation Trust
Windsor SL4 3DP, England, United Kingdom - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Staff Nurse at Frimley Health NHS Foundation Trust
Frimley GU16, England, United Kingdom - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Staff Nurse at Frimley Health NHS Foundation Trust
Slough SL2 4HL, , United Kingdom - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Manager, Business Sustainability at Western Sydney Local Health District
Westmead, New South Wales, Australia - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Senior Clinical Data Analyst at Katalyst Healthcares Life Sciences
Boston, MA 02108, USA - Full Time
Skills Needed
Transformation, Sas, Healthcare Industry, Data Analysis, Power Bi, Python, Data Quality, Regression Analysis, Sql, R, Data Visualization, Presentation Skills, Analytical Techniques, Tableau, Analytics, Biostatistics
Specialization
Engineering, Relevant Field
Qualification
Graduate
Experience Required
Minimum 3 year(s)
Quality Engineer – II at Katalyst Healthcares Life Sciences
Moorpark, California, USA - Full Time
Skills Needed
Fishbone, Microsoft Office, Root, Iso
Specialization
Engineering quality or a related technical field
Qualification
Graduate
Experience Required
Minimum 1 year(s)
Senior Occupational Therapist at Western Sydney Local Health District
Blacktown, New South Wales, Australia - Full Time
Skills Needed
Occupational Therapy, Patient Outcomes
Qualification
Graduate
Quality Engineer II at Katalyst Healthcares Life Sciences
Irvine, CA 92602, USA - Full Time
Skills Needed
Post Market Surveillance, Facilitation, Technical Writing, Psur, Manufacturing Processes
Specialization
A related life science/technical/engineering discipline or equivalent preferred
Qualification
Graduate
Experience Required
Minimum 5 year(s)
Level 1/2 Occupational Therapist at Western Sydney Local Health District
Westmead, New South Wales, Australia - Full Time
Skills Needed
Discharge Planning, Medical Records, Patient Care, Clinical Documentation
Qualification
Graduate
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