Senior Engineer - CSV

• The scope of work for this role is to provide QA Validation support to validation activities associated with of Laboratory instruments and Manufacturing equipment in pharmaceutical industry.
• The responsibility includes review and approval of Qualification/Validation documentation DQ,IQ,OQ,PQ including Risk assessment, specifications, executed protocols, summary reports, deviations, periodic reviews, procedures, and change controls.
• In addition, this role may provide support to the sites data integrity initiative.
• Successful candidate requires a strong working knowledge of global cGMP with an emphasis on validation lifecycle including computer system validation, 21 CFR Parts 210 and 211, and Part 11, Electronic Records and Electronic Signatures
• Candidate requires strong interpersonal, oral and written communication skills as there is a high degree of collaboration required between members of QA Validation/Qualification personnel.
• Candidate must be detail oriented as the main job responsibility is review and approval of validation documentation
• Should also have some experience in Mechanical Qualification

Job Requirements

Skills:

• Strong working knowledge of global GMPs with emphasis on validation, including computer validation
• Strong interpersonal, oral and written skills
• Detail oriented

Education:

• Candidate must have at a minimum a BE or equivalent, engineering or related sciences with pharmaceutical or biopharmaceutical experience in a quality assurance and/or validation/Qualification role.
• Past experience working with Equipment Qualification, Quality Management system, Document, Document Management System, Track wise, and etc.
• Experience working with process manufacturing equipments (RMG, Sifter, Blender, compression m/c, Capsule filling m/c & etc), Utility (Water system, HVAC & etc) and other lab instruments is a plus.