Validation Engineer - GMP Processes & Systems

Ferring Pharmaceuticals SA; Minneapolis (MN); Presencial; USD 77.000 - 110.000; Tempo integral

Benefícios oferecidos por esta vaga

Competitive compensation

Flexible benefits

Resumo da vaga

Ferring Pharmaceuticals SA in Roseville, Minnesota, seeks a Validation Engineer to lead commissioning, qualification, and validation for new processes, materials, equipment, cleaning, and computerized systems/software.

Requires a Bachelor's in engineering and 3–5 years of validation in GMP environments; strong MS Office skills; ability to handle multiple priorities. Competitive compensation and comprehensive benefits are offered.

Qualificações

• Bachelor’s degree in engineering or related field required.
• 3–5 years qualification/validation experience in a GMP environment preferred.
• Experience with process validation and equipment qualification.
• GMP experience in regulated industry required; ability to apply engineering logic to solve problems and assess risks.
• Proficiency with Microsoft Office (Word and Excel).

Responsabilidades

• Support validation activities in a cGMP regulated manufacturing environment.
• Prepare, review, and execute commissioning, qualification and validation documents for processes, materials, equipment, cleaning, and computerized systems/software.
• Support Project Teams in GMP Impact Assessments, User Requirement Specifications, Traceability Matrices, Design Qualifications and Risk Assessments.
• Manage multiple commissioning, qualification, and validation priorities with guidance from management.
• Participate in validation projects including new or transferred processes and cleaning validations.
• Design and execute engineering (pre-validation) studies to support validation activities.
• Assist in troubleshooting process issues, process characterization, and root cause investigations.
• Resolve deviations/non-conformances observed during qualification and validation activities.
• Prepare/issue change controls, CAPAs, and investigations.

Conhecimentos

Engineering problem solving

Risk assessment

GMP knowledge

Project coordination

Formação

Bachelor’s degree in engineering or related field

Ferramentas

Microsoft Word

Microsoft Excel

Computerized System Validation Software

Descrição da vaga

Ferring Pharmaceuticals SA in Roseville, Minnesota, seeks a Validation Engineer to lead commissioning, qualification, and validation for new processes, materials, equipment, cleaning, and computerized systems/software.

Requires a Bachelor's in engineering and 3–5 years of validation in GMP environments; strong MS Office skills; ability to handle multiple priorities. Competitive compensation and comprehensive benefits are offered.