Sr. Validation Scientist - Juncos, Puerto Rico - Mirus Consulting Group

Descripción

mirus Consulting Group is a local company based in Humacao, Puerto Rico that provides computer system validation and information technology consulting services to pharmaceutical companies and other organizations across the Island and parts of the United States. Its services include the assessment and validation of automation equipment, network infrastructures and business processes, as well as the involved project management.

Job Description

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.

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

Preferred Qualifications

Experience in Aseptic Process Simulation (Media Fills), Airflow Visualization Studies (Smoke Studies), Environmental Characterization/QualificationExperience in Parenteral Manufacturing, Isolators

Experience in CDOCs, KNEAT, MS Office

Education

Doctorate degree or Master's degree and 3 years of validation experience or Bachelor's degree and 5 years of validation experience or Associate's degree and 10 years of validation experience or High school diploma / GED and 12 years of validation experience.

Microbiology, Life Sciences, Engineering

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

This Company is an equal employment opportunity employer. We adhere to a policy of making employment decisions without regard to race, color, religion, sex, sexual orientation, national origin, citizenship, age or disability. We assure you that your opportunity for employment with this Company depends solely on your qualifications.