Validation Engineer

Need Validation Engineer for pharmaceutical manufacturing equipment and controls.

BS in Engineering or Science related discipline preferred.                       

Minimum 0-5 years’ experience in FDA-regulated industry

Experience working directly with manufacturing equipment.

Ability to author / review / Modify Templates as required.

Assess impact of process / equipment or procedural changes that can affect the validated state of the equipment.

Must have an understanding of computer system validation including knowledge of cGMP, GAMP 5 and CFR 21 Part.

Must have the ability to develop validation protocols (IQ and OQ), validation reports, and factory acceptance test documents.

Responsible for the writing of and the execution of project and system qualifications, validations, re-qualifications and revalidation of manufacturing facilities, equipment, utilities, and processes.

Excellent computer skills including knowledge of calibration management and environmental monitoring systems

Strong problem-solving skills, strong verbal and written

Able to initiate deviations, be responsible for CAPA investigation and closure as required.