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

• 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.

• 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.

• 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.

• 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.

Qualifications:

• Bachelor Degree in Engineering (any field) or scientific background (Biology, Microbiology, Biotechnology, Chemistry, etc.)

• Five (5) years of related experience

• Previous experiences in regulated environment (Biotechnology, Pharmaceutical, Medical Devices, etc.).

• Advanced validation knowledge (equipment qualification, cleaning, sterilization).

• Applies extensive technical validation expertise and has full knowledge of other related disciplines.

• Experience in Validation with preference in Process Validation.

• Understands regulatory trends in industry and able to make connection between those trends and established corporate direction.

• In-depth knowledge of validation processes and requirements

• Working knowledge of financial analysis tools.

•  Basic project management.

• 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

• Shift: 8hrs shift - Due to the nature of the work (support to new product introductions, projects optimization and commercial manufacturing) non-standard shift might be required (coverage outside day shift such as second/third shifts, weekends, holidays)

  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.

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