Validation Engineer I

Kindeva Drug Delivery • St. Louis, MO

1d • Onsite

About The Position

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.

This role assists with the development of Aseptic product manufacturing equipment qualification/validation, Cleaning Validation & Process validation protocols, performs testing and writes validation reports. The Validation Engineer I generates validation protocols using templates and is primarily responsible for the execution of protocols for various types of basic processing equipment under the direction of the Validation Manager. This includes, but is not limited to, cleaning (CIP & COP) equipment, washers, sterilizers, depyrogenation ovens, fillers, formulation mixing systems, HVAC systems, incubators, freezers, refrigerators, and assembly equipment. The role also involves issuing data, memos, and reports concerning these projects, helping to determine process capability of new equipment, and ensuring defined parameters are incorporated into operating procedures and batch records. Additionally, the Validation Engineer I performs special projects as assigned, adheres to all company and GMP procedures and safety regulations, assists with validation activities performed by outside companies, and supports the Site Change Management Program to maintain compliance with industry standards and regulatory filings.

Requirements

• 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.

Nice To Haves

• 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.

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

What This Job Offers

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