Jt486 - Sr. Validation Scientist

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.

Qualifications:

• Bachelor's degree in related area (Microbiology, Biology, Chemistry, Engineering)
• 5 years of directly related experience
• Experience in Aseptic Process Simulation (Media Fills), Airflow Visualization Studies (Smoke Studies), Environmental Characterization/Qualification
  Experience in Parenteral Manufacturing, Isolators
• Previous experiences in regulated environment (Biotechnology, Pharmaceutical, Medical Devices, etc.).
• Experience in Validation with preference in Process Validation.
• Basic project management.
•  Working knowledge of financial analysis tools.
• Understands regulatory trends in industry and able to make connection between those trends and established corporate direction.
•  Advanced validation knowledge (equipment qualification, cleaning, sterilization).
• Administrative shift (the staff needs to be available to work on any shift including weekends when required for on the floor executions)

Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity,, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.