Sunstar Americas, Inc. | Validation Engineer

As a member of the Sunstar Group, Sunstar Americas, Inc., a global organization dedicated to improving overall health through oral health worldwide, holds a prominent position in the oral care industry. Formerly known as the John O. Butler Company, we are renowned for our exceptional production and distribution, and high-quality oral care products. With our headquarters in Schaumburg, Illinois, and branches in Canada, Mexico, Colombia, Brazil, and Argentina, as well as distribution partners in Central and South America, we have established ourselves as an industry leader.At Sunstar Americas, Inc., we firmly believe that our people are the foundation of our success. We foster a collaborative, innovative, and agile culture that ensures we deliver high-quality, innovative products to consumers and oral care professionals. Our team-oriented approach encourages creative thinking and nurtures a positive work environment and productive relationships. With dedication, hard work, and a shared vision, we can continue to make SAI a leader in our industry.Position Summary:The Validation Engineer is responsible for ensuring that all systems are running according to necessary specifications and operate within regulations to ensure the production of quality products, and to establish documented evidence thereof.Essential Job Functions: Establish validation standards (SOPs)Learn and understand the applicable process technologies and engage in technical discussionsDevelop testing protocols for pharmaceutical systems and equipment validations, including process IQ, OQ, PQ, test method validation, cleaning systems validation, packaging systems validation, and computer systems validation).Serve as protocol Study Director as required.Review deviations and impact to the overall protocol.Collect and interpret data using appropriate statistical tools, compose validation summary reports.Review change control to determine the appropriate level of revalidation required.Maintain validation records.EducationBachelor's Degree in Science or EngineeringKnowledgeExperience Qualified candidates will possess five years of experience in the medical device or pharmaceutical industries, and have a working knowledge of FDA drug and medical device regulations.Experience with standard pharmaceutical industry process and packaging equipment and software, including mixing, filling, and sealing equipment for liquids, gels, and lotions, purified water systems, walk-in coolers, CIP systems, manufacturing control software (PLC, HMI, etc.).Experience in executing protocols including process validation, computer controlled systems validation, complex utilities controls, and equipment validations.Understanding of SPC, Design of Experiments, ANOVA and various other statistical techniques.SkillsCoordinate with end users and process owners to lead development of appropriate protocols.Proficient in Microsoft Word, Excel, and Project management software.Candidates must have strong verbal communication and technical writing skills.Ability to work independentlyWhat Makes Sunstar Special is:A business focused on health and wellness of people around the worldHigh Quality ProductsBeautiful state-of-the-art facilityDiversity and InclusionCorporate Social Responsibility Program and partnership with charitable organizationStrong value placed on company cultureExcellent, comprehensive insurance coverage that includes Medical, Vision, and Dental benefits.Opportunities for career growth and advancementEmployee discount on Sunstar products401K retirement plan with 2.5% employer match (Pretax and Roth options)401K profit sharing contribution based on company performance.Paid holidays and generous paid time off. Pet, Legal and Identity Theft Insurance PlansCompetitive bonusOn-site caféOn Site Fitness CenterCorporate Perks Discount Program (Auto, Retail, Electronics, Entertainment, Computers, Personal Vacations, Cell Phones, Movie Tickets, Eating Out and Much More)Holiday LunchesBeautifully maintained walking trailsHybrid Schedule (certain departments)Numerous employee appreciation events throughout the year.Recognition and Rewards ProgramsAnniversary, Birthday and New Hire AnnouncementsIf you'd enjoy a career helping others attain overall health through oral health, consider joining the Sunstar Americas, Inc. team.The employer is subject to certain governmental record keeping and reporting requirements for the administration of civil rights laws and regulations. In order to comply with these laws, the employer invites employees to voluntarily self-identify their gender, and race or ethnicity. Completion of this data is voluntary and will not affect your opportunity for employment or terms or conditions of employment. Information collected will be used for EEO-1 reporting purposes only and will be kept separate from all other personnel records, only accessed by Authorized Users. Information collected will be kept confidential and will only be used in accordance with the provisions of applicable laws, including those that require the information to be summarized and reported to the federal government. When reported, data will not identify any specific individual.The pay range for this position of Validation Engineer is $79,902-119,853. However, base pay offered may vary depending on skills, experience, job-related knowledge and location. This position is also eligible for an annual bonus as part of total compensation.

Created: 2025-01-16