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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:

+ Under general supervision, provides characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects environment.

+ Applies basic engineering principles to the design and implementation of system modifications, experiments and/or capital projects.

+ Responsible for enhancing system reliability focusing on equipment availability, downtime reduction and maintenance optimization.

+ Function as a technical expert to equipment or systems regarding troubleshooting operations.

+ Frequently become actively involved in daily operations when required to meet schedules or to resolve complex problems.

+ Routinely audit the operational performance and regulatory compliance of a moderate number of equipment items or systems of significant complexity.

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

+ Work under the direct supervision of project managers to complete design, engineering, and construction projects within schedule and budget constraints.

+ Work with consultants, architects and engineering firms on development of standard design documents.

+ Obtain and critique quotes for equipment modifications or installations.

+ Generate rudimentary project cost estimates and schedules.

Qualifications:

+ Bachelor of Science in Chemical, Electrical or Mechanical Engineering.

+ Usage of PI Vision or Process Book tool, P&ID, knowledge in fermentation and purification.

+ 2 years of Engineering experience

+ Working knowledge of pharmaceutical/biotech processes

+ Familiarity with validation processes

+ Familiarity with documentation in a highly regulated environment

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

+ Ability to interpret and apply GLPs and GMPs.

+ Ability to apply engineering science to production.

+ Able to develop solutions to routine technical problems of limited scope

+ Problem solving and applied engineering.

+ Basic technical report writing

+ Comprehensive understanding of validation protocol execution requirements.

+ Rotating shift | 12hrs shift 5pm to 5:30am (Mon, Thu, Fri, Mon, Tue, Sat, Sun)

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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