jt062 - sr. validation scientist - Juncos

Solo para miembros registrados Juncos, Puerto Rico

hace 1 día

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. · In this role, you'll work with a highly enthusiastic team, contributing in a world-clas ...

Descripción del trabajo

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team.

In this role, you'll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

Responsibilities:
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

Qualifications:
Bachelor's degree in related area (Microbiology, Biology, Chemistry, Engineering)
5 years of directly related experience
Advanced validation knowledge (equipment qualification, cleaning, sterilization)
Applies extensive technical validation expertise and has full knowledge of other related disciplines
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 organizations validation programs and practices
Validation Experience in Parenteral Manufacturing
Specifically experience focused in Aseptic Process Validation, Aseptic Techniques, Environmental Monitoring Performance Qualifications, Environmental Characterizations, Airflow Visualization (Smoke Tests)
Experience writing protocols and reports and executing inside clean rooms
Administrative shift