Validation Engineer I

Kindeva • St. Louis, MO

3d • Onsite

About The Position

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

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