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Validation Engineer
3 weeks ago
PSC Biotech Los Angeles, United StatesJob Description · Job DescriptionPSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements. · Our goal is to ...
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Validation Engineer
4 weeks ago
Katalyst HealthCares & Life Sciences Los Angeles, United StatesResponsibilities: · Lead the design, development, implementation, and execution of test scripts/test plans to identify software problems and their causes. · Coordinate and execute performance and functional testing associated with multiple concurrent development and/or infrastr ...
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Validation Engineer
2 weeks ago
Katalyst HealthCares & Life Sciences Los Angeles, United StatesResponsibilities: Lead the design, development, implementation, and execution of test scripts/test plans to identify software problems and their causes. · Coordinate and execute performance and functional testing associated with multiple concurrent development and/or infrastruc ...
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Validation Engineer
1 week ago
PSC Biotech Los Angeles, United StatesJob Description · PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements. · Our goal is to skyrocket our c ...
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Sr. Validation Engineer
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VTI Life Sciences Los Angeles, United StatesVTI Life Sciences (VTI) is seeking forward-thinking and ambitious engineers looking to accelerate their career in the pharmaceutical, biotechnology and medical device industries. We offer an opportunity to help support our teams of industry subject matter experts and thought lead ...
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Sr. Validation Engineer
3 weeks ago
VTI Life Sciences Los Angeles, United StatesVTI Life Sciences (VTI) is seeking forward-thinking and ambitious engineers looking to accelerate their career in the pharmaceutical, biotechnology and medical device industries. We offer an opportunity to help support our teams of industry subject matter experts and thought lead ...
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Sr. Validation Engineer
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BioPhase Solutions Los Angeles, United StatesJob Description · Job DescriptionBioPhase Solutions specializes in recruiting top talented professionals for Southern California's Scientific community. We are currently looking for a contract Sr. Validation Engineer to work for a leading Greater Los Angeles area biotechnology co ...
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Sr. Validation Engineer
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Takeda Pharmaceuticals Los Angeles, United StatesBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I sub ...
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Sr. Validation Engineer
3 weeks ago
Inc. (Vti) Los Angeles, United StatesVTI Life Sciences (VTI) · is seeking forward-thinking and ambitious engineers looking to accelerate their career in the pharmaceutical, biotechnology and medical device industries. We offer an opportunity to help support our teams of industry subject matter experts and thought l ...
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Senior Validation Engineer
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SciPro Inc. Los Angeles, United StatesSenior Validation Engineer (Contract) · Location: · Van Nuys Area · Role Overview · We're seeking a highly skilled Senior Validation Engineer for a temporary onsite role. Reporting to the Manager of Quality Engineering, you'll support our quality engineering team with documenta ...
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Sr. Validation Engineer
3 weeks ago
Takeda Pharmaceutical Company Ltd Los Angeles, United StatesBy clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takedas Privacy Notice and Terms of Use. I further attest that all information I submit ...
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Senior Validation Engineer
1 week ago
ImmPACT Bio Los Angeles, United StatesImmPACT Bio USA, Inc., is a clinical-stage company dedicated to the discovery of transformative chimeric antigen receptor (CAR) T-cell therapies that address key biological challenges in treating cancer and autoimmune diseases. The company's logic-gate-based CAR T-cell platforms, ...
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Validation Engineer
1 week ago
Azzur Group Los Angeles, United StatesThe ideal candidate will have expertise in environmental monitoring, protocol generation, · execution of qualification activities, and documentation updates. Experience with room · environmental monitoring equipment Installation, Operational and Performance · Qualification (IO ...
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Validation Engineer
1 week ago
BioPhase Los Angeles, United StatesSummary of Job: · The Validation Engineer is responsible for designing, planning, writing, and executing protocols and studies. This role involves managing, coordinating, facilitating, and implementing process, equipment, software, and product validations and qualifications. The ...
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Validation Engineer
1 week ago
Azzur Group Los Angeles, United StatesWe are looking for a Validation Engineer with a minimum of 3 years of experience who · possesses a strong understanding of autoclave cycle development and syringe fill/finish · principles. The ideal candidate will be responsible for developing and optimizing autoclave · steril ...
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Validation Engineer
1 week ago
Azzur Group Los Angeles, United StatesThe ideal candidate will have expertise in environmental monitoring, protocol generation, · execution of qualification activities, and documentation updates. Experience with room · environmental monitoring equipment Installation, Operational and Performance · Qualification (IO ...
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Validation Engineers
3 weeks ago
Inc. (Vti) Los Angeles, United StatesVTI Life Sciences (VTI) · is seeking forward-thinking and ambitious engineers looking to accelerate their career in the pharmaceutical, biotechnology and medical device industries. We offer an opportunity to help support our teams of industry subject matter experts and thought l ...
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Validation Engineer
3 weeks ago
PSC Biotech Los Angeles, United StatesJob Description · PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements. · Our goal is to skyrocket our ...
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Validation Engineers
3 weeks ago
VTI Life Sciences Los Angeles, United StatesVTI Life Sciences (VTI) is seeking forward-thinking and ambitious engineers looking to accelerate their career in the pharmaceutical, biotechnology and medical device industries. We offer an opportunity to help support our teams of industry subject matter experts and thought lead ...
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Validation Engineer
1 week ago
Katalyst HealthCares & Life Sciences Los Angeles, United StatesResponsibilities: · Lead the design, development, implementation, and execution of test scripts/test plans to identify software problems and their causes. · Coordinate and execute performance and functional testing associated with multiple concurrent development and/or infrastr ...
Clean Validation Engineer - Los Angeles, United States - Trinity Consultants
Description
ADVENT's services include process engineering, automation engineering, project engineering, HVAC/facility system design, process development, start up and commissioning, validation and compliance consulting for distinguished and successful biotechnology and pharmaceutical manufacturing companies.
The successful candidate will work with a group of engineers involved in the design, automation, commissioning and start-up of various processes, systems, and facilities.
Responsibilities
Utilize engineering, vendor, and client specifications to generate and execute testing protocols for process equipment and utility systems following client procedures and good documentation practices
Assist in deviation root cause analysis and corrective action plans
Generate final and summary reports for executed test protocols
Provide technical and compliance input into project execution strategies to ensure regulatory requirements are met.
Generate and support higher level project documentation as required such as Masterplans, schedules, and summary reports.
Working in the full range of Biotech/pharma project phase execution including all design phases, construction, startup, CQV, and project hand-over activities.
You may be involved with other aspects such as client-management (maintain key Client relationships in support of business development and pursuit of new work), project scheduling/budgeting, coordination of client and ADVENT resources for effective project delivery, supporting business development (providing technical support to the sales as required for proposals/opportunities), presenting at industry conferences/publishing papers etc.
Qualifications5 to 12 years of experience in biotech, pharmaceutical, medical device, or academic or environment
Cleaning and Process Validation
i. Generating/executing validation protocols and authoring final summary reports.
Familiarity with upstream and downstream processes and equipment.
Working with cross-functional teams (Validation, QC, Engineering, QC, etc.) to develop cleaning and process validation strategies.
Experience writing and executing commissioning, verification, and validation protocols and associated reports
Familiar with integrated commissioning and validation as well as ASTM E2500 verification methods
Experience utilizing risk based methodologies in testing
Experience with manufacturing processes and equipment such as CIP/COP systems, filtration skids, chromatography, fermentors/bioreactors, sterilization, and lyophilization equipment
Experience with hygienic utility systems such as purified water, WFI, clean steam, and process air
Experienced with Office software such as Word and Excel
Experience with testing equipment and software such as Kaye Validators and Dataloggers
Engineering or Scientific degree
Travel may be required on occasion
Permanent FTE or temporary/contract options available
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