Validation Engineer
- Compensation
- Not disclosed
- Location
- Minneapolis, Minnesota, United States
- Work setup
- Not specified
- Seniority
- Not specified
- Employment
- Full time
- Experience
- 3+ years
- Category
- Industrial engineering
- Posted
Skills
Must have
- · Bachelor’s degree in engineering or relevant field or equivalent experience
- Experience:
- · Minimum 3-5 years qualification/validation experience. Experience in the following areas preferred:
- o Material Qualification
- o Computerized System/Software Validation
- o Process Validation
- o Regulated industry experience required (GMP Preferred)
- o Ability to apply sound engineering logic to solve complex problems, assess risks, and make decision accordingly
- o Proficiency with Microsoft Office programs such as Word and Excel
- Ferring + you
- At Ferring, we offer competitive total compensation along with an exceptional range of flexible benefits, personal support and tailored learning and development opportunities all designed to help you
- Our Compensation and Benefits
- At Ferring, base salary is one part of our competitive total compensation and benefits package and is determined using a salary range. The base salary range for this role is $76,500 to $110,000, which
- Benefits for this role include comprehensive healthcare (medical, dental, and vision) with a premium differential, inverse to base salary, to be paid by employees, a 401k plan and company match, short
- Ferring is an equal opportunity employer. All aspects of employment will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, m
- Join our team and your voice will be heard, and your contributions will be valued. If you love to come up with new ways to make a positive difference and see them through, you will fit right in.
- We are proud to be an Affirmative Action/Equal Opportunity Employer (including Disability/Protected Veterans). We maintain a drug-free workplace.
Full description
Job Description:
Ferring pioneers and delivers life-changing therapies that help people build families and live better lives. Our independence helps us cultivate an entrepreneurial spirit and long-term perspective that enables us to achieve growth and scale, while remaining agile and true to our ‘people first’ philosophy. Built on a 70-year plus commitment to science and research, Ferring is relentless in its pursuit of science that drives powerful discoveries and therapies to help people build families, stay healthy, and stand up to the world’s oldest enemy: disease.
Summary: The Validation Engineer will be responsible for preparing and executing commissioning, qualification, and validations for new processes, materials, equipment, cleaning, and computerized systems/software.
Responsibilities: The responsibilities of the Validation Engineer include the following but are not limited to:
· Support validation activities in a cGMP regulated manufacturing environment. The position will 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.
· Ability to handle multiple commissioning, qualification, and validation priorities based on the needs of the manufacturing area and project team with guidance from management.
· Participating in and support validation projects within the manufacturing areas including but not limited to:
o Validation and implementation of new or transferred manufacturing process and cleaning validations.
o Design and execute engineering (pre-validation) studies to support validation activities.
o Assist in troubleshooting process issues, process characterization and root cause investigations.
o Involved in resolving deviations/non-conformances observed during execution of qualification and validation activities.
o Ability to prepare/issue change controls, CAPAs, and investigations.
OTHER JOB FUNCTIONS:
· Other duties and tasks assigned
Requirements:
· Bachelor’s degree in engineering or relevant field or equivalent experience
Experience:
· Minimum 3-5 years qualification/validation experience. Experience in the following areas preferred:
o Material Qualification
o Computerized System/Software Validation
o Process Validation