Validation & Engineering Group
Sr. Validation Specialist with Bachelor Degree in Science or Engineering
Validation & Engineering Group, San Juan, San Juan, us, 00902
Sr. Validation Specialist with Bachelor Degree in Science or Engineering
Full-time
Validation & Engineering Group, Inc. is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, among other services.
The Validation Engineer will support the characterization of process optimization strategies and/or troubleshoot operational issues in the operations, manufacturing, pilot plant or capital projects environment. Apply basic engineering principles to the design and implementation of system modifications, experiments and/or capital projects. Organize, analyze and present interpretation of results for operational issues to engineering projects of minor scope and complexity. Work with consultants, architects and engineering firms on the development of standard design documents.
Working knowledge of pharmaceutical/biotech processes
Working knowledge with validation processes
Working knowledge with documentation in a highly regulated environment
Ability to operate specialized laboratory equipment and computers as appropriate
Ability to interpret and apply GLPs and GMPs
Ability to apply engineering science to production
Able to develop solutions to routine technical problems of limited scope
Demonstrated skills in the following areas:
Problem solving and applied engineering
Basic technical report writing
Verbal communication
Comprehensive understanding of validation protocol execution requirements
Demonstrated skills in the following areas:
Basic technical presentations
Personal organization
Validation protocol writing
Dealing with and managing change
Technical (Equipment Specific)
Analytical problem solving
Computer literacy
Specialized equipment/process expertise
In-depth knowledge of validation processes and requirements as applied to new equipment installations
Interacts effectively with variety of communication and working styles
Ability to independently determine when additional internal resources are required to solve problems
Ability to handle multiple projects at one time
Demonstrated skills in the following areas:
Schedule development
Facilitation
Collaboration
Basic project management
Completion and follow-up
Established expertise in at least 3 separate areas of engineering technology
Ability to independently determine when additional external resources are required to solve problems
Ability to provide solutions to a large variety of technical problems of moderate to large complexity and scope
Problem solving skills requiring the application of scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach
Working knowledge of financial analysis tools
Ability to delegate and manage the project work of others
Demonstrated skills in the following areas:
Negotiation, persuasion and facilitation
Collaboration
Project cost development
Conflict resolution
Leadership and teambuilding
Basic knowledge in vision systems
Basic knowledge in equipment controls (PLC, HMI, Servodrives, etc)
Basic knowledge in medical devices or combination products
Basic knowledge in lean manufacturing, six sigma or quality by design
Basic knowledge in statistics
Basic knowledge in metrology
Basic knowledge in plastic molding process
Basic knowledge of medical device assembly process
Basic knowledge of packaging of medical devices or pharmaceutical products
Basic knowledge in safety training (MSDS, equipment safety, etc)
Positions available for Puerto Rico.
Validation and Engineering Group, Inc is an Equal Employment Opportunity employer.
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Full-time
Validation & Engineering Group, Inc. is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, among other services.
The Validation Engineer will support the characterization of process optimization strategies and/or troubleshoot operational issues in the operations, manufacturing, pilot plant or capital projects environment. Apply basic engineering principles to the design and implementation of system modifications, experiments and/or capital projects. Organize, analyze and present interpretation of results for operational issues to engineering projects of minor scope and complexity. Work with consultants, architects and engineering firms on the development of standard design documents.
Working knowledge of pharmaceutical/biotech processes
Working knowledge with validation processes
Working knowledge with documentation in a highly regulated environment
Ability to operate specialized laboratory equipment and computers as appropriate
Ability to interpret and apply GLPs and GMPs
Ability to apply engineering science to production
Able to develop solutions to routine technical problems of limited scope
Demonstrated skills in the following areas:
Problem solving and applied engineering
Basic technical report writing
Verbal communication
Comprehensive understanding of validation protocol execution requirements
Demonstrated skills in the following areas:
Basic technical presentations
Personal organization
Validation protocol writing
Dealing with and managing change
Technical (Equipment Specific)
Analytical problem solving
Computer literacy
Specialized equipment/process expertise
In-depth knowledge of validation processes and requirements as applied to new equipment installations
Interacts effectively with variety of communication and working styles
Ability to independently determine when additional internal resources are required to solve problems
Ability to handle multiple projects at one time
Demonstrated skills in the following areas:
Schedule development
Facilitation
Collaboration
Basic project management
Completion and follow-up
Established expertise in at least 3 separate areas of engineering technology
Ability to independently determine when additional external resources are required to solve problems
Ability to provide solutions to a large variety of technical problems of moderate to large complexity and scope
Problem solving skills requiring the application of scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach
Working knowledge of financial analysis tools
Ability to delegate and manage the project work of others
Demonstrated skills in the following areas:
Negotiation, persuasion and facilitation
Collaboration
Project cost development
Conflict resolution
Leadership and teambuilding
Basic knowledge in vision systems
Basic knowledge in equipment controls (PLC, HMI, Servodrives, etc)
Basic knowledge in medical devices or combination products
Basic knowledge in lean manufacturing, six sigma or quality by design
Basic knowledge in statistics
Basic knowledge in metrology
Basic knowledge in plastic molding process
Basic knowledge of medical device assembly process
Basic knowledge of packaging of medical devices or pharmaceutical products
Basic knowledge in safety training (MSDS, equipment safety, etc)
Positions available for Puerto Rico.
Validation and Engineering Group, Inc is an Equal Employment Opportunity employer.
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