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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:

+ Complete complex or novel assignments requiring development of new and/or improved engineering techniques and procedures.

+ Develop engineering policies and procedures that affect multiple organizational units.

+ Supervise, coordinate and review work of a small staff of engineers, associates and/or technicians on an ongoing basis as well as on a project basis.

+ Employ advanced engineering techniques and/or modifications of advanced techniques within area of engineering expertise.

+ Apply knowledge of engineering principles and practices outside of area of discipline expertise to broad variety of assignments in related fields.

+ Serves as a peer-recognized engineering technology specialist in at least one area, with overall responsibility for determining methodologies in that area.

+ Application of mature engineering knowledge in planning and conducting projects.

+ Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity.

+ Work with research, manufacturing, process development, utilities, facilities, quality assurance and validation departments in developing requirements and recommendations for large and/or highly complex system/facility modifications.

+ Work with project managers to complete design and engineering projects within schedule, budget and quality constraints.

+ Coordinate the work of consultants, architects and engineering firms on development of standard design documents.

+ Develop departmental budgets or project budgets encompassing multiple disciplines for area within project or entirety of smaller project.

Qualifications:

+ Bachelors in Chemical or Mechanical Engineering

+ +4 years of engineering experience

+ Strong background in regulated environments with ability to apply GMP in manufacturing and validation.

+ Experience in drafting, executing, and approving validation, (e.g. Validation Protocol Writing).

+ Hands-on experience with time pressure filling systems.

+ Experience in preparing, reviewing, and approving protocols, reports, and strategy presentations.

+ Experienced in designing protocols for complex systems such as filling lines and aseptic processes.

+ Strong written and verbal communication in English and Spanish.

+ Proven experience working with QA, Manufacturing, and Engineering teams during critical activities.

+ Ability to operate specialized laboratory equipment and computers as appropriate.

+ Ability to interpret and apply GLPs and GMPs.

+ Willing and able to support non-standard shifts, including nights, weekends, and extended hours.

+ Administrative Shift

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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