Validation Engineer

NACS, Inc.; Ham Lake (MN); Vor Ort; USD 90.000 - 105.000; Vollzeit

Zusammenfassung

Ascential Medical & Life Sciences in Ham Lake, MN seeks a seasoned Asset Validation Engineer to lead validation strategies for equipment, facilities, instruments and software in a cGMP setting. You will design, implement, and continuously improve validation programs to ensure performance and regulatory compliance.

Responsibilities include authoring IQ/OQ/PQ protocols and master plans, overseeing data collection and analysis, and collaborating with Manufacturing, Quality Assurance, IT and

Qualifikationen

• Proven track record of leading complex validation projects in a cGMP environment.
• In-depth knowledge of FDA, EU, ISO, and ICH regulations and standards.
• 3 years: Experience in validation disciplines within regulated life sciences (Pharmaceutical, Biologics, Medical Devices, Combination Prodcuts)
• Preferred experience with automated systems, cleanroom equipment, and laboratory.

Aufgaben

• Design, implement, and continuously improve equipment validation and asset lifecycle programs.
• Manage qualification and validation activities for facilities, equipment, instruments, systems, and software.
• Author and approve validation master plans, IQ/OQ/PQ protocols, and summary reports.
• Ensure documentation meets regulatory and internal quality standards.
• Oversee and execute validation protocols with accurate data collection and analysis.
• Interpret results to confirm equipment performance, reliability, and compliance.
• Collaborate with Manufacturing, Facilities, Quality Assurance, IT and external clients to support validation projects.

Kenntnisse

Project leadership

Regulatory knowledge

cGMP experience

Documentation

Ausbildung

Bachelor's degree in Engineering or related field

Jobbeschreibung

Ascential Medical & Life Sciences
Ham Lake, MN 55304, USA

• On-site
• Travel Required : No
• Full-Time
• Requisition #: VALID001803

Description

Asset Lifecycle and Validation Program

• Support the design, implementation, and continuous improvement of equipment validation and asset lifecycle programs.
• Manage qualification and validation activities for facilities, equipment, instruments, systems, and software.

Protocol and Report Development

• Author and approve validation master plans, protocols (IQ/OQ/PQ), and summary reports.
• Ensure documentation meets regulatory and internal quality standards.

Execution and Analysis

• Oversee and execute validation protocols, ensuring accurate data collection and analysis.
• Interpret results to confirm equipment performance, reliability, and compliance.

Regulatory Compliance

• Ensure all validation activities comply with FDA, EU, ICH, ISO and relevant standards.

Risk Assessment and Mitigation

• Conduct and lead risk assessments (e.g., FMEA) to identify potential failure modes and implement mitigation strategies.

Cross-Functional Collaboration

• Partner with Manufacturing, Facilities, Quality Assurance, IT, Program Management, and external clients to support validation projects and resolve technical issues.

Maintenance of Validated State

• Manage requalification and revalidation activities following equipment changes, upgrades, or periodic reviews.
• Maintain validated state documentation and change control records.

Salary Range: $90,000 - $105,000 depending on qualifications

Travel Required

No .

Qualifications

Education

Preferred

Bachelors or better in Engineering or related field.

Experience

Required

Proven track record of leading complex validation rojects in a cGMP environment

In-depth knowledge of FDA, EU, ISO, and ICH regulations and standards

3 years: Experience in validation disciplines within regulated life sciences (Pharmaceutical, Biologics, Medical Devices, Combination Prodcuts)

Preferred

Experience with automated systems, cleanroom equipment, and laboratory

Equal Opportunity Employer
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