Senior Validation Engineer

Kindeva Drug Delivery • St. Louis, MO

21h • Onsite

About The Position

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.
The Impact You Will Make
The Senior Validation Engineer will assist in the development of Aseptic product manufacturing equipment qualification/validation, Cleaning Validation & Process validation protocols and perform testing and write validation reports.

Requirements

• Bachelor’s degree in Chemistry, Biochemistry, Microbiology, Engineering, Pharmacy or related science.
• 7+ 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

• Generate validation protocols using templates.
• Protocol execution of various types of basic processing equipment under the direction of Validation Manager.
• 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.
• 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: Mid Level
• Number of Employees: 1,001-5,000 employees