Validation Engineer Exp with biological equipment validation exp min 5 yrs of pure validation Onsite

MillenniumSoft Inc; San Diego (CA); On-site; USD 70,000 - 110,000; Full time

Job summary

Ein etabliertes Unternehmen im Bereich Medizintechnik sucht einen engagierten Validierungsingenieur mit mindestens 5 Jahren Erfahrung in der Validierung biologischer Geräte. In dieser Rolle sind Sie verantwortlich für die Durchführung von Validierungsstudien, die Sicherstellung der Einhaltung von Qualitätsrichtlinien und regulatorischen Standards sowie die Unterstützung von QA-Inspektionen. Sie werden in einem dynamischen Umfeld arbeiten, in dem Ihre Expertise in Prozess- und Gerätevalidierung geschätzt wird. Wenn Sie eine Leidenschaft für Qualitätssicherung haben und einen bedeutenden Beitrag zu innovativen Lösungen leisten möchten, ist dies die perfekte Gelegenheit für Sie.

Qualifications

• Mindestens 5 Jahre Erfahrung in der Validierung von biologischen Geräten.
• Kenntnisse in Qualitätssystemen und Risikoanalyse.

Responsibilities

• Durchführung von Validierungsstudien für Geräte und Prozesse.
• Wartung und Unterstützung biologischer Geräte aus Qualitätssicht.

Skills

Kommunikationsfähigkeiten

Statistische Analyse (Minitab, Excel)

Prozess- und Gerätevalidierung

ISO 13485

ISO 9001

ISO 14971

Six Sigma

SAP

Education

BSc in Biological Sciences

BSc in Chemistry

BSc in Bio-tech Engineering

Tools

Minitab

Excel

SAP

Job description

Validation Engineer Exp with biological equipment validation exp min 5 yrs of pure validation Onsite

Join to apply for the Validation Engineer with biological equipment validation experience, minimum 5 years of pure validation, onsite role at MillenniumSoft Inc.

Position Details

• Title: Validation Engineer - Biological Equipment Validation (Min 5 Years)
• Location: San Diego, CA
• Duration: 12 Months
• Hours/week: 40
• Shift: 1st Shift
• Client: Medical Devices Company
• Category: Engineering
• Experience Level: Mid-Level
• Employment Type: Contract on W2 (US Citizens, GC Holders, GC EAD, OPT, EAD, CPT)

Job Description

The Validation Engineer is responsible for executing validation activities for manufacturing equipment and supporting process validation or verification studies, ensuring compliance with quality policies and regulatory standards.

Responsibilities

• Perform equipment and process validation studies, including protocol writing, data analysis, and reporting.
• Maintain and support biological equipment from a quality perspective, including preventive maintenance and calibration.
• Author and execute qualification protocols for analytical and manufacturing equipment.
• Validate GMP equipment across manufacturing facilities.
• Review and update risk management documents related to validation.
• Support manufacturing relocations and ensure business continuity.
• Assist in QA inspections and document reviews for product release.

Qualifications

• BSc in Biological Sciences, Chemistry, Bio-tech Engineering, or related field.
• 3-5 years of experience for QE II, 5-7 years for senior roles in medical device, biotech, or pharma industries.

Skills and Knowledge

• Excellent communication skills, knowledge of quality systems, statistical analysis (Minitab, Excel).
• Strong understanding of process and equipment validation, ISO 13485, ISO 9001, ISO 14971, and risk management.
• Experience with Six Sigma, SAP, and equipment management systems.
• Ability to work independently and in teams, organized, detail-oriented, self-motivated.

Physical & Work Environment

• Ability to work in controlled environments with laboratory equipment.
• Onsite presence required in manufacturing areas.

Additional Details

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Quality Assurance

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