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10 Jul 2023
Full-Time Validation Associate Engineer
Job Description
Location:Roseville, Minnesota
Job Description
Summary: The Validation Associate Engineer will be responsible for preparing and executing commissioning, qualification, and validations for new processes, materials, equipment, cleaning, and computerized systems/software.
Responsibilities include 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.
Qualifications
Education:
- Bachelor’s degree in Engineering or relevant field or equivalent experience
Experience:
- Minimum 1-3 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
Additional Information
All your information will be kept confidential according to EEO guidelines
How to Apply
Apply here: https://smrtr.io/fDX5j https://www.ferring.com/join-us/your-career-at-ferring/ Please visit our career site for similar and more open roles Referrer: Milanie Noriega66 total views, 0 today