Senior Engineer – GMP Packaging Process & Validation Lead

Cis-International-LLC

Juncos (PR)

On-site

USD 90,000 - 130,000

Full time

21 hours ago

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Job summary

Cis-International-LLC in Juncos, PR seeks a senior design engineer to independently characterize and implement process optimization strategies across operations, manufacturing, pilot plants or capital projects. You will apply advanced engineering principles to major system modifications and present results for complex issues.

You will lead a small team, develop procedures, coordinate with QA, validation, utilities, and ensure GMP/GDP compliance with emphasis on validating new equipment and

Qualifications

Deep knowledge of pharmaceutical/biotech manufacturing processes and compliance with GMP/GDP.
Experience designing or modifying complex systems in pharma settings.
Ability to write test protocols and perform technical evaluations.

Responsibilities

Develop and apply advanced engineering techniques for major system modifications.
Supervise and coordinate engineers/technicians on projects.
Coordinate with project managers, consultants, architects and vendors on design documents.
Prepare budgets for multi-discipline projects and ensure schedule adherence.

Skills

Pharma/biotech processes

Validation processes

GLPs & GMPs

Engineering problem solving

Team leadership

Project management

Technical communication

Adaptability in evolving environment

Education

Doctorate or Masters + 2 years experience

Bachelors in Engineering + 4 years experience

Tools

Laboratory equipment

Computers

Job description

You will lead a small team, develop procedures, coordinate with QA, validation, utilities, and ensure GMP/GDP compliance with emphasis on validating new equipment and

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