Senior Validation Engineer - Aseptic Pharma & Biotech

Veg Group; Carolina (PR); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Dietary allowances

Job summary

Validation & Engineering Group, Inc. seeks a Sr Engineer to independently characterize and optimize processes in manufacturing, pilot plants or capital projects. You will develop, organize and present analyses for complex engineering issues and lead system modifications.

Ideal candidates have aseptic experience, PQ/NPI exposure, and strong regulatory knowledge, with fluency in English and Spanish. Occasional extended hours may be required in a regulated environment.

Qualifications

• Engineer with aseptic processing experience including Fill/Finish lines.
• Experience in characterization activities and PQ for NPI.
• Experience in pharmaceutical/medical device/biotech industries.
• Experience in direct process/manufacturing areas.
• Bilingual in English and Spanish with strong communication skills.
• Proficient with Windows and MS Office.
• Knowledge of cGxP and regulatory guidance for compliance.
• Experience in design documentation (URS, DS), IQ, OQ, PQ protocols and deviations.
• Understand SDLC, risk assessment, data integrity, FAT/SAT.
• Available for extended hours including weekends/holidays.

Responsibilities

• Characterize process optimization strategies and troubleshoot operations.
• Design and implement major system modifications and capital projects.
• Analyze and present results for complex engineering issues.

Skills

Aseptic processing

Fill/Finish

Characterization

NPI PQ

Process/manufacturing

Bilingual English/Spanish

MS Office

cGxP/compliance

URS/DS/IQ/OQ/PQ

SDLC/Risk Assessment

Data Integrity

FAT/SAT

GLPs/GMPs

Lab equipment operation

Education

Masters + 2 years engineering experience

Bachelors in Engineering + 4 years

Preferred: Mechanical or Chemical Engineering

Tools

MS Windows

Microsoft Office

Job description

Validation & Engineering Group, Inc. seeks a Sr Engineer to independently characterize and optimize processes in manufacturing, pilot plants or capital projects. You will develop, organize and present analyses for complex engineering issues and lead system modifications.

Ideal candidates have aseptic experience, PQ/NPI exposure, and strong regulatory knowledge, with fluency in English and Spanish. Occasional extended hours may be required in a regulated environment.