Sr Validation Scientist (31810) – Juncos, PR

Requirements Education/Experience
Doctorate degree OR Master’s degree and 3 years of directly related experience OR Bachelor’s degree and 5 years of directly related experience in Science or Engineering OR Associate’s degree and 10 years of directly related experience OR High school diploma / GED and 12 years of directly related experience.

Preferred: Science or Engineering

Preferred Qualifications
Commissioning and Qualification, Computer Validation (CSV)

Description:
Client requires all staff, staff augmentation external workers, and certain other external workers, in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of assignment. In accordance with applicable law, client will provide reasonable accommodations to staff augmentation external workers who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to client, its operations, or its staff.

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

EDUCATION/LICENSES
– 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.

COMPETENCIES/SKILLS
– 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.

Administrative Shift