Full-Time Validation Engineer
Job Description
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.
- Supports 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.
Participates in and supports validation projects within the manufacturing areas including but not limited to:
- Validation and implementation of new or transferred manufacturing process and cleaning validations.
- Design and execute engineering (pre-validation) studies to support validation activities.
- Assisting in troubleshooting of process issues, process characterization and root cause investigations.
- Involved in resolving deviations/non-conformances observed during execution of qualification and validation activities.
- Ability to prepare/issue change controls, CAPAs, and investigations.
OTHER JOB FUNCTIONS:
- Other duties and tasks as 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:
- Material Qualification
- Computerized System/Software Validation
- Process Validation
- Regulated industry experience required (GMP Preferred)
- Ability to apply sound engineering logic to solve complex problems, assess risks, and make decision accordingly
- Proficiency with Microsoft Office programs such as Word and Excel
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 and perform pre-employment substance abuse testing.
Ferring offers a competitive total compensation package inclusive of but not limited to the following benefits: medical, dental, vision, 401(k), vacation policy, paid holidays, sick days, paid maternity/paternity leave, tuition reimbursement, flexible savings accounts, short-term disability, long-term disability, life and AD&D insurance
Location:Roseville, Minnesota
How to Apply
click and apply here: https://smrtr.io/g8t2g Visit our career site: Your Career at Ferring - Ferring Global Referrer: Milanie Noriega35 total views, 0 today