Validation Engineering

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 writes validation reports. Generates validation protocols using templates. Primarily responsible for protocol execution of various types of basic processing equipment under the direction of Validation Manager (For example (but not limited to) the following: cleaning (CIP & COP) equipment, washers, sterilizers, depyrogenation ovens, fillers, formulation mixing systems, HVAC systems, incubators, freezers, refrigerators, and assembly equipment).

Issues data, memos, and reports concerning above projects.

Helps determine process capability of new equipment through execution of approved protocols and ensures defined parameters are incorporated into respective operating procedures and batch records.

Performs special projects as assigned by department manager.

Adheres to all company and GMP procedures, along with safety regulations within the plant.

Assists with validation activities performed by outside validation companies; ensures that department and company policies are adhered to.

Assists 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+ years of 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.

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.

Job Family B - Engineering - Validation Engineering

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