Validation Engineer I

Kindeva Drug Delivery • St. Louis, MO

1d

About The Position

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world. The successful candidate will assist in the 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. The position requires knowledge of cGMP and associated industry and regulatory guidance documents. The candidate must have demonstrated proficiency in project management skills and must be able to balance multiple priorities.

Requirements

• BS in Chemistry, Biochemistry, Microbiology, Engineering, Pharmacy or related science and 3+ 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.
• 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.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level