Validation Engineer

With worldwide headquarters in Atlanta, CIBA Vision is a global leader in the research, development and manufacturing of optical and ophthalmic products and services, including contact lenses and lens care products. CIBA Vision products are available in more than 70 countries worldwide.Reporting to the Healthy Wear Quality Head, this position is responsible for all types of validation including equipment, computer systems, process and cleaning. This person is responsible for developing and executing validation documentation to maintain processes and equipment in a validated state. The position will require experience in the validation of PLCs, computer systems, manufacturing processes, sterilization equipment, packaging lines, utilities and other process equipment.This person should be experienced with SOPs, change control and resolving deviations.The candidate should have experience in validation in a FDA regulated environment including experience with cGMP, 21 CFR Part 11. Experience with ISO 13485:2003 and SOX is considered an asset.QualificationsBS or MS in Engineering, computer sciences or physical/life sciences. Experience in equipment and process validation in a FDA regulated industry. Be hands-on and field experienced. Excellent time management skills. Knowledge of GMP requirements. Self starter with strong process improvement and quality skills. Excellent written and oral communication skills. Ability to manage multiple projects simultaneously. Excellent decision making skills.REQUIRED YEARS OF EXPERIENCE: BS/BA in related discipline. 5+ years experience in pharmaceutical or medical device industry. MS/MA in related discipline. 2+ years experience in pharmaceutical or medical device industry.PREFERRED QUALIFICATIONS: MS in Engineering. Significant computer and software validation including MRP/ERP.
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