- Perform room qualification activities including temperature mapping, environmental monitoring (differential pressures, particulate monitoring, etc.), and other activities
- associated with facility qualification.
- Qualification of equipment such as autoclaves and chambers (temperature mapping, cycle development, etc.).
- Generate protocols, summary reports, and protocol exceptions for validation activities.
- Schedule and execute qualification activities according to project timelines.
- Collect and analyze qualification data against acceptance criteria.
- Update documentation including Standard Operating Procedures (SOPs), forms, and other relevant documents.
- Attend meetings and coordinate projects with cross-functional teams.
- Validation Engineer with 4-6 years of experience in a regulated industry.
- Experience in room environmental monitoring qualification.
- Proficiency in executing equipment IOPQ protocols (e.g., autoclaves, chambers, etc.).
- Aseptic gowning experience is a plus.
- Knowledge of cleaning validation processes is preferred.
- Strong report writing skills.
- Bachelors degree in Engineering or related field; Masters degree preferred.
- 2-5 years of experience in validation engineering or related field.
- Knowledge of regulatory requirements, including FDA and ISO standards.
- Excellent communication and coordination skills.
- Ability to work effectively in a cross-functional team environment.
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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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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
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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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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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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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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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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 - Los Angeles, United States - Azzur Group
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Description
The 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 (IOPQ), aseptic gowning, and cleaning validation is highly desirable.
Key Responsibilities