GMP Validation Engineer – Processes & Systems

USA LE; Minneapolis (MN); Presencial; USD 77.000 - 110.000; Tempo integral

Benefícios oferecidos por esta vaga

Healthcare (medical, dental, andvision

401(k) with company match

Disability insurance

Life Insurance

Wellness benefits

Tuition reimbursement

Paid time off

Paid holidays

Annual incentive/bonus targets

Resumo da vaga

Ferring is seeking a Validation Engineer to prepare and execute commissioning, qualification, and validation for processes, materials, equipment, cleaning, and computerized systems/software. The role supports validation activities in a cGMP manufacturing environment and collaborates with project teams on GMP impact assessments, traceability matrices, and risk assessments.

You will manage multiple validation priorities, participate in pre-validation studies, assist in deviation investigations,

Qualificações

• 3–5 years qualification/validation experience in a regulated environment.
• Experience with Material Qualification, Computerized System/Software Validation and Process Validation.
• GMP experience and structured problem-solving approach.

Responsabilidades

• Support validation activities in a cGMP manufacturing environment and prepare/execute QC documents.
• Assist in GMP Impact Assessments, User Requirements, Traceability Matrices and Risk Assessments.
• Coordinate multiple validation priorities with management guidance.
• Validate new or transferred processes and cleaning validations; perform pre-validation studies.
• Troubleshoot process issues and participate in deviations, CAPAs, and investigations.
• Assist in change controls and investigations; take on other duties as assigned.

Conhecimentos

Validation experience

Risk assessments

Engineering problem solving

Formação

Bachelor's degree in engineering or relevant field

Ferramentas

Microsoft Office (Word, Excel)

Descrição da vaga

Ferring is seeking a Validation Engineer to prepare and execute commissioning, qualification, and validation for processes, materials, equipment, cleaning, and computerized systems/software. The role supports validation activities in a cGMP manufacturing environment and collaborates with project teams on GMP impact assessments, traceability matrices, and risk assessments.

You will manage multiple validation priorities, participate in pre-validation studies, assist in deviation investigations,