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Validation Engineers
1 week 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
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 infrastruc ...
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Validation Engineers
1 week 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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Equipment Validation Engineer
3 weeks ago
Katalyst HealthCares & Life Sciences Los Angeles, United StatesResponsibilities: The candidate should have expertise in (verification) testing, systems and methods qualification & validation, and maintenance of Laboratory Equipment · Experience designing validation protocols for Equipment Validation, including IQ/OQ/PQ and reports is requi ...
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Sr. Validation Engineer
4 weeks ago
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
1 week ago
Takeda Pharmaceutical Los Angeles, CA, 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 su ...
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Senior Validation Engineer
3 weeks 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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Clean Validation Engineer
5 days ago
Trinity Consultants Los Angeles, United StatesADVENT'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 manufac ...
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Sr. Validation Engineer
3 days 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 l ...
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Sr. Validation Engineer
3 weeks ago
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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Senior Validation Engineer
1 week ago
BioPhase Los Angeles, United States*US Citizens or Greencard Holders only* · Work Schedule: · Onsite - M-F · Salary: · $60-70/hr · Duration: · 4 months · Primary Responsibilities: · Support the Quality Engineering group with documentation and validation needs. · Draft URS documents, design specifications, tes ...
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Sr. Validation Engineer
1 week 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 Takeda's Privacy Notice and Terms of Use. I further attest that all information I subm ...
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Sr. Validation Engineer
3 days ago
BioPhase Solutions Los Angeles, United StatesJob Description · Job Description · BioPhase 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 bi ...
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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
3 weeks 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
2 weeks 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
2 weeks 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
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 infrastr ...
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Validation Engineer
3 weeks 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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Senior Quality/Validation Engineer
1 week ago
Meet Los Angeles, United StatesAn exciting clinical-stage biotech company, located in the Los Angeles area, is seeking a talented professional to join a their team as a Senior Quality Engineer. · Key Responsibilities: · Ensure continuous validation of Equipment, Facilities, Utilities, and Computer Systems. ...
validation engineer - Los Angeles, United States - Apartment Association of Orange County
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Description
Summary 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 focus is on implementing new facilities, equipment, and process improvements, ensuring compliance with policies and procedures, and meeting customer requirements.
Specific Duties and Responsibilities:
Develop, implement, manage, and integrate Qualification and Validation plans for all production activities and products.
Design testing criteria and procedures, including acceptance criteria for validation purposes.
Perform all aspects of the validation program (URS, DQ, IQ, OQ, PQ).
Identify risks, process gaps, and quality issues, and mitigate them through validation activities.
Handle new facility/equipment/process validations, process and equipment changes, and periodic requalification/revalidation.
Provide validation, engineering, and process expertise for developing new processes.
Conduct testing, including setup, execution, and data collection.
Construct and execute controlled experiments.
Support the development and execution of FATs, SATs, DQ, IQ, OQ, PQ, and other relevant life cycle documents for validation.
Support the development and update of validation master plans, project plans, SOPs, risk assessments, user requirements, cleaning assessments, and technical assessment reports.
Requirements:
Bachelors degree in science or equivalent work experience.
3-4 years of experience in a GMP or ISO regulated environment.
Experience with oligo synthesis manufacturing.
Ability to interpret regulatory standards (USP and ISO) and develop risk-based decisions ensuring compliance with governance.
Familiarity with domestic and international GMP regulations (e.g., 21 CFR 210).
Strong understanding of quality risk management principles, including best practices in risk-based C&Q approach.
Hands-on experience in developing validation documentation and field execution.
1-2 years of experience in a quality-related role in a controlled work environment.
Experience in executing studies and/or validation protocols.
ASQ certification (CQA or CQE) is a plus.
Excellent organizational, negotiation, problem-solving, and time-management skills.
Self-motivated and willing to tackle assignments and development opportunities outside of job scope as needed.
Ability to interpret engineering and facility drawings (facility layouts, blueprints, material/process flow diagrams, and equipment P&IDs).
Expert skills in Microsoft Word and PowerPoint, and intermediate skills in Microsoft Excel.
Understanding of basic statistics, acceptance sampling, and familiarity with statistics software (Minitab and JMP).
Attention to detail and decisive action capability.
Ability to work under pressure, manage multiple tasks simultaneously, and meet tight deadlines.
Excellent interpersonal, written, oral presentation, and verbal communication skills.
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