Senior Process Engineer – C&Q & Validation Leader

CIS International LLC; Juncos (PR); On-site; USD 120,000 - 160,000; Full time

Job summary

CIS International LLC seeks an experienced Design/Commissioning Engineer to lead qualification strategies and oversee IQ/OQ/PQ across GMP biotech environments. You will drive risk assessments for system qualification and coordinate with Engineering, Validation, QA, Manufacturing and Supply Chain to deliver complex projects.

Responsibilities include developing documentation, validating systems, and mentoring junior engineers.

Qualifications

• Doctorate or Master’s degree with 2+ years engineering experience.
• Bachelor’s degree in Engineering with 4+ years engineering experience.
• Experience in validated pharmaceutical/biotech environments and regulated documentation.

Responsibilities

• Lead the design, execution and review of qualification protocols (IQ/OQ/PQ).
• Develop and implement commissioning & qualification strategies aligned with project needs.
• Coordinate with Engineering, Validation, QA, Manufacturing and Supply Chain teams.
• Ensure GMP/GLP compliance and ALCOA+ data integrity in all QC/documentation.
• Mentor junior engineers and provide technical guidance across projects.

Skills

Pharma/biotech processes

Validation processes

Documentation in regulated env

GLPs and GMPs

Engineering in production

Problem solving

Technical report writing

Verbal communication

Education

Doctorate

Masters + 2 years eng exp

Bachelors in Engineering

Job description

CIS International LLC seeks an experienced Design/Commissioning Engineer to lead qualification strategies and oversee IQ/OQ/PQ across GMP biotech environments. You will drive risk assessments for system qualification and coordinate with Engineering, Validation, QA, Manufacturing and Supply Chain to deliver complex projects.

Responsibilities include developing documentation, validating systems, and mentoring junior engineers.