Validation Engineer

Ferring Pharmaceuticals•Roseville, MN

10d•$76,500 - $110,000

About The Position

The Validation Engineer prepares and executes commissioning, qualification, and validation activities for new processes, materials, equipment, cleaning, and computerized systems/software in a cGMP-regulated manufacturing environment. The role supports project teams and manufacturing areas, managing multiple priorities with guidance from management. It also contributes to engineering studies, troubleshooting, process investigations, and resolution of issues found during qualification and validation work.

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

Material Qualification experience.
Computerized System/Software Validation experience.
Process Validation experience.
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/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 according to manufacturing-area and project-team needs, with guidance from management.
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 observed during qualification and validation execution.
Prepare and issue change controls, CAPAs, and investigations.
Perform other duties and tasks as assigned.

Benefits

Competitive total compensation and benefits package.
Flexible benefits, personal support, and tailored learning and development opportunities.
Comprehensive healthcare coverage, including medical, dental, and vision insurance, with an employee premium differential based on base salary.
401(k) plan with company match.
Short- and long-term disability coverage.
Basic life insurance.
Wellness benefits.
Reimbursement for certain tuition expenses.
Sick time accrual of 1 hour per 30 hours worked.
Vacation accrual for full-time employees: up to 150 hours during the first four years of employment 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.
Annual incentive compensation in the form of an annual bonus based on individual and company performance.