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 discussions
Develop 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.
Education, Knowledge, Skills, and Abilities:
Bachelor’s Degree in Science or Engineering
Qualified Candidates will possess 3-5 years of experience in 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.
Coordinate with end users and process owners to lead development of appropriate protocols.Proficient in Microsoft Word, Excel, and Project management software.
Ability to work independently
Travel up to 10%
Candidates must have strong verbal communication and technical writing skills.
Physical Requirements/Work Environment
May need to sit or stand as needed. May require walking primarily on a level surface for periods during the day. May involve the use of a variety of office equipment such as computers, telephones, copiers, etc. Keyboard usage and frequency can be moderate to extensive. Position will spend a significant amount of time sitting but have the ability to move around. Lifting is minimal and does not routinely exceed ten (10) pounds. There is minimal bending, stooping or twisting involved.
The performance of this position is in a typical office environment with regulated temperatures, good lighting and traditional office equipment. No special Personal Protective Equipment is required. May occasionally require exposure to the manufacturing environment where under certain areas require the use of Personal Protective Equipment such as hearing protection.
Internal Number: 2018-34
About Sunstar Americas
Sunstar Americas, Inc., a member of the Sunstar Group of companies, is a global organization headquartered in Switzerland that is a leader in the oral care industry and the manufacturer and distributor of the GUM and Butler Brands. The company serves oral health care professionals and consumers in 80 countries around the world and is driven by a mission to enhance the health and well-being of people everywhere.