Biotech Process Engineer - Purification & GMP Ops

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, 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.