Sr Validation Scientist

Weil Group•Juncos, PR

About The Position

SUMMARY Independently provides and/or directs the technical validation engineering support of process and/or equipment upgrades, replacements, and modifications in the laboratory, manufacturing or manufacturing support environment. FUNCTIONS - Able to troubleshoot systemic validation issues. - Applies advanced and diverse validation engineering principles to the design and implementation of major system or process modifications and/or capital projects. - Develops, organizes, analyzes and presents interpretation of results for operational issues or validation engineering projects of significant scope and complexity. - Complete complex or novel assignments requiring development of new and/or improved validation engineering techniques and procedures. - Develop validation engineering policies and procedures that affect multiple organizational units. - Supervise, coordinate and review work of a small staff of engineers and/or technicians on an ongoing basis as well as on a project basis. - Employ advanced validation engineering techniques and/or modifications of advanced techniques within area of validation engineering expertise. - Apply knowledge of validation engineering principles and practices outside of area of expertise to broad variety of assignments in related fields. - Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity. - Work with manufacturing, process development, utilities, facilities, labs, and/or quality assurance in developing requirements and recommendations for large and/or highly complex process, system/facility modifications. - Work with project managers to complete the validation responsibilities of engineering projects within schedule, budget and quality constraints. - Develop departmental budgets or project budgets encompassing multiple disciplines for area within project or entirety of smaller project. - Prompt and regular attendance to the workplace. Other functions may be assigned Knowledge : - Advanced validation knowledge (equipment qualification, cleaning, sterilization). - Applies extensive technical validation expertise, and has full knowledge of other related disciplines. Problem Solving: - Provide technical solutions to a wide range of difficult problems. - Solutions are imaginative, thorough, practicable, and consistent with organization objectives. Discretion/Latitude: - Exercises considerable latitude in determining technical objectives of assignment. - Completed work is reviewed from a relatively long- term perspective, for desired results. - Supervision and guidance relate largely to overall objectives, critical issues, new concepts, and policy matters. Impact: - Essential to the completion of broad programs and projects. - Decisions, recommendations and actions form the basis of site/local program schedules and personnel/fiscal resource utilization. Leadership: - Leads efforts of group of peers directly supervises staff or project resources. - Guides the successful completion of major programs and may function in a project leadership role. - May be expected to directly supervise staff or project resources. Liaison: - Represents the organization as the prime technical contact on contracts and projects. - Interacts with senior external personnel on significant technical matters often requiring coordination between organizations. Regulatory: - Understands regulatory trends in industry and able to make connection between those trends and established corporate direction. - Some direct experience with FDA or equivalent regulatory body. - Represents the organization as the technical expert to endorse the organization's validation programs and practices

Requirements

Advanced validation knowledge (equipment qualification, cleaning, sterilization)
Extensive technical validation expertise, and has full knowledge of other related disciplines
Provide technical solutions to a wide range of difficult problems
Solutions are imaginative, thorough, practicable, and consistent with organization objectives
Exercises considerable latitude in determining technical objectives of assignment
Essential to the completion of broad programs and projects
Leads efforts of group of peers directly supervises staff or project resources
Guides the successful completion of major programs and may function in a project leadership role
Represents the organization as the prime technical contact on contracts and projects
Interacts with senior external personnel on significant technical matters often requiring coordination between organizations
Understands regulatory trends in industry and able to make connection between those trends and established corporate direction
Some direct experience with FDA or equivalent regulatory body
Represents the organization as the technical expert to endorse the organization's validation programs and practices
Doctorate degree or Master's degree and 3 years of directly related experience or Bachelor's degree and 5 years of directly related experience or Associate's degree and 10 years of directly related experience or High school diploma / GED and 12 years of directly related experience
In-depth knowledge of validation processes and requirements
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
Technical expertise areas of validation engineering
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, decision making, leadership and teambuilding, management of contractors and vendors

Responsibilities

Provide technical validation engineering support of process and/or equipment upgrades, replacements, and modifications
Troubleshoot systemic validation issues
Apply validation engineering principles to the design and implementation of system or process modifications and/or capital projects
Develop, organize, analyze and present interpretation of results for operational issues or validation engineering projects
Complete complex assignments requiring development of new and/or improved validation engineering techniques and procedures
Develop validation engineering policies and procedures that affect multiple organizational units
Supervise, coordinate and review work of a small staff of engineers and/or technicians
Employ advanced validation engineering techniques and/or modifications of advanced techniques within area of validation engineering expertise
Apply knowledge of validation engineering principles and practices outside of area of expertise to broad variety of assignments in related fields
Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity
Work with manufacturing, process development, utilities, facilities, labs, and/or quality assurance in developing requirements and recommendations for process, system/facility modifications
Work with project managers to complete the validation responsibilities of engineering projects within schedule, budget and quality constraints
Develop departmental budgets or project budgets encompassing multiple disciplines for area within project or entirety of smaller project
Prompt and regular attendance to the workplace