Validation Engineer
Full Time
Camarillo, CA 93010
$80,000 - $90,000 a year
Posted Just posted
Job description
Validation Engineer Needed in Camarillo, CA (in-person)
Pay: $80k - $90k yearly (negotiable)
Reports to : Director of Product Design & R&D
Industry: Biotech, Life Sciences, MedTech, Pharma
Job Summary
The Validation Engineer will collaborate with stakeholders at all company locations to conduct product, process and equipment validations, risk assessments, develop testing methods and various test/process validation requirements. Individual will lead cross functional teams to ensure product or process verification supports all internal and product compliance requirements.
Essential Functions
Education
Bachelor's degree in biology, business, engineering, or closely related field.
Required Experience & Competencies
We are an equal opportunity employer and make hiring decisions based on merit. Recruitment, hiring, training, and job assignments are made without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, or any other protected classif
Pay: $80k - $90k yearly (negotiable)
Reports to : Director of Product Design & R&D
Industry: Biotech, Life Sciences, MedTech, Pharma
Job Summary
The Validation Engineer will collaborate with stakeholders at all company locations to conduct product, process and equipment validations, risk assessments, develop testing methods and various test/process validation requirements. Individual will lead cross functional teams to ensure product or process verification supports all internal and product compliance requirements.
Essential Functions
- Consult with management, evaluate customer requirements, and studies product characteristics to select validation objectives and standards.
- Prepare protocols for validation or performance testing of new or modified manufacturing equipment, processes, or systems.
- Analyze data from validation tests to determine whether systems and processes meet required criteria and specifications.
- Maintain technical records within design history files associated with assigned products.
- Collaborate and coordinates with appropriate departments and staff regarding the scheduling or implementation of validation testing.
- Identify root causes of production problems.
- Identify nonconformities of product or process standard and offers recommendations for resolving deviations.
- Develop and maintain databases for tracking test results, validation activities, or validated systems.
- Develop, maintain, or review validation and compliance documentation including schematics, protocols, and engineering change notices.
- Modify testing methods, revisit test objectives and standards to resolve testing problems.
- Calibrate equipment to ensure accurate measurements.
- Develop test methods, generate, and maintain design specifications, protocol & report writing, prototyping, DOE/SPC product optimization, design verification & validation, FMEA, etc.
- Participate in system-level and subsystem-level root cause investigation from firmware and electrical perspective, coordinate design improvements with development partners, tactical planning, and execution of design changes and improvements.
- Support Product Delivery Teams (PDT), including creating and or reviewing quality documents, participating in Corrective And Preventive Action (CAPA) implementation, and generating or supporting ECR (Engineering Change Request) & ECO (Engineering Change Order)
- Work with Scientists and Engineers internally and externally to assess
- Perform other related duties as assigned.
Education
Bachelor's degree in biology, business, engineering, or closely related field.
Required Experience & Competencies
- 8+ years of experience in quality operations within a biotechnology or pharmaceutical manufacturing facility, or master's degree in science or engineering.
- 3+ years' validation engineering experience.
- Excellent verbal and written communication skills.
- Excellent interpersonal skills.
- Thorough understanding of industry standards and regulatory guidelines.
- Thorough understanding of applicable mathematics and scientific practices.
- Thorough understanding of related equipment and the ability to perform equipment modifications.
- Proficient with Microsoft Office Suite or related software
We are an equal opportunity employer and make hiring decisions based on merit. Recruitment, hiring, training, and job assignments are made without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, or any other protected classif
johnandkristie.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, johnandkristie.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, johnandkristie.com is the ideal place to find your next job.