Validation & Engineering Group, Inc.
Overview
Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the areas of Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
Position Sr Engineer
Responsibilities
1st shift, but it will be required to work 2nd or 3rd shift during CIP Cycle development activities. December shutdown support will be required as well.
Independently provides and/or directs the characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects environment.
Applies advanced and diverse engineering principles to the design and implementation of major system modifications, experiments, process and/or capital projects.
Develops, organizes, analyzes and presents interpretation of results for operational issues or engineering projects of significant scope and complexity.
Develops engineering policies and procedures that affect multiple organizational units.
Supervises, coordinates and reviews the work of a small staff of engineers, associates and/or technicians on an ongoing basis as well as on a project basis.
Employs advanced engineering techniques and/or modifications of advanced techniques within the area of engineering expertise.
Applies knowledge of engineering principles and practices outside of the area of discipline expertise to a broad variety of assignments in related fields.
Serves as a peer-recognized engineering technology specialist in at least one area, with overall responsibility for determining methodologies in that area.
Other functions may be assigned.
Design Engineering
Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity.
Work with research, manufacturing, process development, utilities, facilities, quality assurance and validation departments in developing requirements and recommendations for large and/or highly complex system/facility modifications.
Work with project managers to complete design and engineering projects within schedule, budget and quality constraints.
Coordinate the work of consultants, architects and engineering firms on development of standard design documents.
Develop departmental budgets or project budgets encompassing multiple disciplines for area within project or entirety of smaller project.
Education
Masters + 2 years of Engineering experience OR
Bachelors in Engineering + 4 years of Engineering experience.
Competencies/Skills
Working knowledge of pharmaceutical/biotech processes
Familiarity with validation processes
Familiarity 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
MAXIMO
Experience in commissioning and qualification (C&Q), and installation qualifications in pharmaceutical/biotechnology equipment
Experience in CIP and SIP cycle development
Experience developing project plans and strategies
Organized, multitasking and ability to work in a high-paced environment
Demonstrated Skills
Problem solving and applied engineering
Basic technical report writing
Verbal communication
Comprehensive understanding of validation protocol execution requirements
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Strategy/Planning and Information Technology
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We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
Position Sr Engineer
Responsibilities
1st shift, but it will be required to work 2nd or 3rd shift during CIP Cycle development activities. December shutdown support will be required as well.
Independently provides and/or directs the characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects environment.
Applies advanced and diverse engineering principles to the design and implementation of major system modifications, experiments, process and/or capital projects.
Develops, organizes, analyzes and presents interpretation of results for operational issues or engineering projects of significant scope and complexity.
Develops engineering policies and procedures that affect multiple organizational units.
Supervises, coordinates and reviews the work of a small staff of engineers, associates and/or technicians on an ongoing basis as well as on a project basis.
Employs advanced engineering techniques and/or modifications of advanced techniques within the area of engineering expertise.
Applies knowledge of engineering principles and practices outside of the area of discipline expertise to a broad variety of assignments in related fields.
Serves as a peer-recognized engineering technology specialist in at least one area, with overall responsibility for determining methodologies in that area.
Other functions may be assigned.
Design Engineering
Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity.
Work with research, manufacturing, process development, utilities, facilities, quality assurance and validation departments in developing requirements and recommendations for large and/or highly complex system/facility modifications.
Work with project managers to complete design and engineering projects within schedule, budget and quality constraints.
Coordinate the work of consultants, architects and engineering firms on development of standard design documents.
Develop departmental budgets or project budgets encompassing multiple disciplines for area within project or entirety of smaller project.
Education
Masters + 2 years of Engineering experience OR
Bachelors in Engineering + 4 years of Engineering experience.
Competencies/Skills
Working knowledge of pharmaceutical/biotech processes
Familiarity with validation processes
Familiarity 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
MAXIMO
Experience in commissioning and qualification (C&Q), and installation qualifications in pharmaceutical/biotechnology equipment
Experience in CIP and SIP cycle development
Experience developing project plans and strategies
Organized, multitasking and ability to work in a high-paced environment
Demonstrated Skills
Problem solving and applied engineering
Basic technical report writing
Verbal communication
Comprehensive understanding of validation protocol execution requirements
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Strategy/Planning and Information Technology
#J-18808-Ljbffr