Validation Engineer Job at MillenniumSoft Inc (San Diego)

Job Description

In-depth knowledge of product development, extensive experience in scale up, process improvements, validation and transfer of production processes to Operations. Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment in determining the scope and timing of transfer activities. Exercises judgement within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results. Responsible for improving process efficiency and product quality. Determines methods and procedures on new assignments.

Job Responsibility

Represents Reagent operations in new product teams as the core team member
Transfers products and processes into manufacturing following the Global Product Development System
Develops strategies and carries out plans to stabilize and reduce production cost of new products
Generates manufacturing plan based on the product requirements and the anticipated manufacturing resources needed to produce and ship the new product
Prepares and submits SOP’s, WI’s, BOM’s, routings and standard costing for new product into SAP
Provides floor support
Independently performing root cause analysis for product complaints through experiments involving flow cytometry/applications and production process evaluations including physical property or analytical data analysis
Responsible for the timely documentation of the results and conclusions
Evaluates failures, writes Variance Reports (VR's), presents recommendations to Material Review Board
Analyzes and solves complex and challenging problems in Production and Quality Control
Provides support by providing flow cytometry expertise to experimental strategy, problem characterization, data acquisition and analysis
Evaluates product history, recommends revisions to product specifications, originates Change Orders (CO's)
Identifies areas for improvements in product quality, process capability and production costs
Applies Lean and Six Sigma practices into the development, scale up and setup of the manufacturing processes
Design, writing and execution of Gage R&R, scale up, stability, and validation studies
Design, Write and Implement all development activities and reports, validation protocols for manufacturing E&P
Ensures validation of equipment and processes, evaluates data and writes reports
Interfaces with Product Development, Research, Quality, Regulatory and Production to bring new technologies, methods, and tests into Manufacturing
Evaluates technologies and processes for reliability, production capability, consistency, and cost effectiveness
Makes recommendations for process improvements
Assists and mentors fellow associates to develop skills and techniques
Trains Chemists/Technicians in processes and procedures
Keeps abreast of the basic requirements for compliance of their work
Participates as required in training on regulatory issues affecting own area of work
Brings regulatory compliance questions/issues to the attention of management
Promotes a safe work environment
May provide recommendations on maintaining the safety of the work environment
Participates in Environmental Health and Safety programs
Addresses corrective actions whenever a hazard is identified
Notifies supervisor of all observed hazardous conditions or unsafe work practices

Requirements

Bachelor degree with 7 years of experience
Master’s degree with 5 years of experience
PhD with 2 years of Industry experience in biological sciences or related field
6 years of experience in FDA or ISO regulated production environment
At least one year of experience in managing a large or complex project
Experience in statistical analysis, Six Sigma
Technical expertise in molecular biology/antibody techniques, instrumentation, and assays performed
Project management experience
Experience in SAP/ related Enterprise management

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Validation Engineer

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