Our Work Matters At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world. Role Responsibilities • Assists with development of Aseptic product manufacturing equipment qualification/validation, Cleaning Validation & Process validation protocols, 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 (For example (but not limited to) the following: cleaning (CIP &COP) equipment, washers, sterilizers, depyrogenation oven, fillers, formulation mixing systems, HVAC systems, incubators, freezers, refrigerators and assembly equipment). • Issue data, memos and reports concerning above projects. • 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. • Perform special projects as assigned by department manager. • Adhere to all company and GMP procedures, along with safety regulations within the plant. • 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 Qualifications • BS in Chemistry, Biochemistry, Microbiology, Engineering, Pharmacy or related science • 3+ plus years related experience and/or training; or equivalent combination of education and experience. • Knowledge of cGMP and internal SOPs and general knowledge of associated industry and regulatory guidance documents preferred. • Sound working knowledge of the operation of various pharmaceutical processing equipment, labeling/packaging equipment and integrated inspection equipment preferred. #LI-ON-SITE
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Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.
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