Validation Engineer

Ferring • Roseville, MN

9d

About The Position

The Validation Engineer prepares, reviews, and executes commissioning, qualification, and validation documents and activities for processes, materials, equipment, cleaning, and computerized systems or software in a cGMP-regulated manufacturing environment. The role supports project teams with GMP impact assessments, user requirement specifications, traceability matrices, design qualifications, and risk assessments. The engineer manages multiple priorities with guidance from management and contributes to validation projects in manufacturing areas, including new or transferred processes and cleaning validations, engineering studies, troubleshooting, process characterization, root-cause investigations, and resolution of deviations and non-conformances. Other duties may be assigned.

Requirements

• Bachelor’s degree in engineering or a relevant field, or equivalent experience.
• Minimum 3–5 years of qualification/validation experience.
• Experience in a regulated industry is required; GMP experience is preferred.
• Ability to apply sound engineering logic to solve complex problems, assess risks, and make decisions accordingly.
• Proficiency with Microsoft Office programs such as Word and Excel.

Nice To Haves

• Experience in material qualification.
• Experience in computerized system/software validation.
• Experience in process validation.
• GMP experience.

Responsibilities

• 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 or software.
• Support project teams with GMP impact assessments, user requirement specifications, traceability matrices, design qualifications, and risk assessments.
• Manage multiple commissioning, qualification, and validation priorities based on manufacturing-area and project-team needs, with guidance from management.
• Participate in and support validation projects in manufacturing areas, including validation and implementation of new or transferred manufacturing processes and cleaning validations.
• Design and execute engineering (pre-validation) studies to support validation activities.
• Assist with troubleshooting process issues, process characterization, and root-cause investigations.
• Help resolve deviations and non-conformances identified during qualification and validation activities.
• Prepare or issue change controls, CAPAs, and investigations.
• Perform other duties and tasks as assigned.

Benefits

• Competitive total compensation and annual incentive bonus based on individual and company performance.
• Flexible benefits, personal support, and tailored learning and development opportunities.
• Comprehensive healthcare, including medical, dental, and vision coverage, with employee premium contributions varying inversely with base salary.
• 401(k) plan and company match.
• Short- and long-term disability coverage.
• Basic life insurance.
• Wellness benefits.
• Reimbursement for certain tuition expenses.
• Sick time of 1 hour per 30 hours worked.
• Vacation accrual for full-time employees, up to 150 hours in the first four years and 187.5 hours in the fifth year.
• 15 paid holidays per year.
• Paid parental leave, subject to a minimum period of employment at Ferring.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level