Job description

Top Skills - Must Haves

• Validation protocols
• Test methods
• Root Cause / CAPA
• Medical / Pharmaceutical industry experience preferred

Secondary Skills - Nice to Haves

• Technical writing
• Medical device
• Iq
• Oq
• Pq
• Validation
• Validation testing
• Iso 13485
• Equipment validation
• Root cause analysis
• Corrective action plans

Job Description

• 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) activities.
• Work with Scientists and Engineers internally and externally to assess and develop appropriate design and manufacturing specifications.
• Perform other related duties as assigned.

Additional Skills & Qualifications

• • Bachelor’s degree preferred in Engineering
• • 3+ years’ validation engineering experience.
• • Technical writing experience
• • Experience with product and/or equipment validation (IQ / OQ / PQ)

Job Type: Full-time

Pay: $100,000.00 - $115,000.00 per year

Benefits:

• 401(k) matching
• Dental insurance
• Health insurance
• Retirement plan
• Vision insurance

Experience level:

• 10 years
• 11+ years
• 3 years
• 4 years
• 5 years
• 6 years
• 7 years
• 8 years
• 9 years

Schedule:

• 8 hour shift
• Monday to Friday

Work setting:

• In-person

Ability to commute/relocate:

• Camarillo, CA 93012: Reliably commute or planning to relocate before starting work (Required)

Work Location: In person

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