JT631 - ENGINEER

Quality Consulting Group, LLC; Juncos (PR); On-site; USD 60,000 - 85,000; Full time

Job summary

Quality Consulting Group, LLC is seeking a talented, highly motivated engineer to join our team in Puerto Rico and the USA. You’ll work on process optimization, troubleshooting in operations, manufacturing, and capital projects, applying engineering principles to design and implement system modifications.

The role involves collaborating with research, manufacturing, QA, and validation to develop requirements, generate cost estimates, and ensure regulatory compliance with GLPs and GMPs.

Qualifications

• Bachelor's degree in engineering.
• 2 years of engineering experience.
• Experience in biotechnology processes, purification operations, chromatography and UFDF.
• 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.
• 1st shift (8hrs)

Responsibilities

• Characterize process optimization strategies and troubleshoot operational issues in operations, manufacturing, pilot plant or capital projects.
• Apply basic engineering principles to design and implement system modifications and experiments.
• Organize, analyze and present interpretation of results for operational issues or engineering projects of minor scope and complexity.
• Function as a technical expert to equipment or systems regarding troubleshooting operations.
• Routinely audit the operational performance and regulatory compliance of equipment or systems of significant complexity.
• Collaborate with research, manufacturing, maintenance, process development, utilities, facilities, quality assurance and validation departments.
• Work under supervision to complete design, engineering, and construction projects within schedule and budget.
• Coordinate with consultants, architects and engineering firms on standard design documents.
• Obtain and critique quotes for modifications or installations.
• Generate rudimentary project cost estimates and schedules.
• Other functions may be assigned.

Skills

GLPs & GMPs

Lab equipment operation

Regulated documentation

Engineering problem solving

Chromatography

UFDF techniques

Education

Bachelor's degree in engineering

Job description

QUALITY CONSULTING GROUP, a leader inthe 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.
• Organizes, analyzes and presents interpretation of results for operational issues or engineering projects of minor scope and complexity.
• Operations Engineering:
• 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.
• Design Engineering:
• 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.
• Other functions may be assigned.

Qualifications

• Bachelor's degree in engineering.
• 2 years of Engineering experience
• Experience in biotechnology processes, specifically in purification operations. Knowledge in chromatography and UFDF techniques
• 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.
• 1st shift (8hrs)

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.