Senior Validation Engineer — On-site, cGMP Life Sciences

NACS, Inc.; Ham Lake (MN); In loco; USD 90.000 - 105.000; Tempo pieno

Descrizione del lavoro

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

Competenze

• 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.

Mansioni

• 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.

Conoscenze

Project leadership

Regulatory knowledge

cGMP experience

Documentation

Formazione

Bachelor's degree in Engineering or related field

Descrizione del lavoro

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