Equipment Validation Engineer
Location
Northridge, CA | United States
Job description
Hello Everyone,
This is Vydehi from Intellectt Inc. One of our clients is looking for Equipment Validation Engineer in CA. If you are interested with the below Job description please send me your updated resume to my email [email protected]
Job Title : Equipment Validation Engineer
Location : Northridge,CA
Duration : 12 months (Possibility of extension)
POSITION DESCRIPTION:
- The QC Team tests multiple TDD and IDD products in house. Right now there are 40 pieces of lab equipment this is out of spec or needs to be validated. The lab currently outsource multiple test to 3rd parties but if the equipment was all working they could do it all in house. This continuous improvement project is let the QC lab utilize and take advantage of their equipment.
- The candidate should have expertise in (verification) testing, systems and methods qualification & validation, and maintenance of Laboratory Equipment
- Experience designing validation protocols for QC Lab Equipment, including IQ/OQ/PQ and reports is required
- Experience qualifying analytical laboratory equipment and/or systems within a life sciences environment
- Solid knowledge of qualification/validation principles and their practical applications
- Direct experience developing and executing validation protocols
- Tactical thinker with experience working with customers developing testing, validation and/or quality strategies
- A team player with excellent verbal, written and interpersonal communication skills
- Excellent written and verbal communication skills, with the ability to prepare clear and concise validation documentation
- Detail-oriented mindset with a focus on accuracy and compliance
- Ability to work independently as well as collaboratively in a cross-functional team environment
- Strong organizational and time management skills to manage multiple validation projects simultaneously
- Responsibilities
- The Validation Engineer will work in the Laboratory Operations group and collaborate across functions (e.g. quality, IT, and vendors) and assist Device Engineers and Laboratory staff in developing practical and thorough solutions to problems, and execute validation activities: method validation, equipment qualification, computer system validation, and method transfer
- This objective will be accomplished by executing the following activities: Coordinate and execute commissioning and qualification of laboratory equipment and computer systems (e.g. hardware, software, and accessory systems) for use in regulated and non-regulated operations
- Supporting activities include URS review, Assessments (System Impact, Requirements Risk, CSV Risk, Part 11)
- Design Qualification, Commissioning Protocols, IQ/OQ/PQ Protocols and Summary Reports remotely
- Development and execution of qualification and validation documentation according to GAMP 5 guidance for Analytical Laboratory Test Equipment, Instruments, and Systems
- Documentation includes, but not limited to: Risk Assessments, Validation Plans, Design Specifications, User Requirements, Functional Requirements, IQ/OQ/PQ Protocols, Requirements Traceability Matrices, and Summary Reports
- Utilization of Benchtop Laboratory equipment / Lab equipment such as Autoclaves, Isolators, Centrifuge, Water Bath, Incubator, Glasswasher, Karl Fisher, Colony Counter, Plate Reader, Refrigerator
- Development of SOPs, Maintenance Procedures, Calibration Procedures, and other instrument support documentation
- Initiating and leading change controls for implementation of new instrumentation in biopharmaceutical drug delivery and parenteral pharmaceutical therapeutic environments
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