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Kelly Scientific is seeking an experienced Validation Scientist/Process Engineer to join one of our partners for an assignment on-site in Roseville, MN.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.
JOB REQUIREMENTSBachelor’s degree in Science/Engineering or relevant field or equivalent 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 suite
JOB DETAILSJob Type: 6-month assignment
Location: Roseville, MN
Pay rate: dependent on experience
#P2
Full-time