Senior Validation Engineer

Our Work Matters At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world. The Impact You Will Make The Senior Validation Engineer will assist in the development of Aseptic product manufacturing equipment qualification/validation, Cleaning Validation, Process validation, computer systems validation, perform testing and write validation reports.  This individual will generate validation protocols using templates and be responsible for protocol execution of various types of basic processing equipment under the direction of Validation Manager. This role is required to be on-site at the Bridgeton facility and relocation assistance is available for qualified candidates who are not local to the St. Louis area.   Essential Job Functions: Assists with development of Aseptic product manufacturing equipment qualification/validation, Cleaning Validation & Process validation protocols, computer systems validation, performs testing and write validation reports. Generate validation protocols using templates. Primary responsible for protocol execution of various types of basic processing equipment under the direction of Validation Manger. Help to determine process capability of new equipment through execution of approved protocols and assures defined parameters are incorporated into respective operating procedures and batch records. Assist with validation activities performed by outside validation companies; assures that department and company policies are adhered to. Assist with the Site Change Management Program to keep all finished products, equipment, processes and facilities in compliance with contemporary industry standards and regulatory filings.   Basic Qualifications: Bachelor’s degree in Chemistry, Biochemistry, Microbiology, Engineering, Pharmacy or related science 7 years validation related experience in an aseptic environment. Knowledge of cGMP and internal SOPs and general knowledge of associated industry and regulatory guidance documents. Sound working knowledge of the operation of various pharmaceutical processing equipment, labeling/packaging equipment and integrated inspection equipment. Ability to read, analyze and interpret common scientific and technical journals; comprehend equipment manuals and translate operational limits into protocols acceptance criteria; able to readily identify/report deviations to management in a timely manner.  To perform this job successfully, an individual should have a working knowledge of Microsoft Office (Word, Excel, Outlook, Access, and Projects).     #LI- On-Site