Senior Validation Engineer

Our Work Matters

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 inspection, assembly and packaging product manufacturing equipment qualification/validation, process validation protocols, computer systems validation, and performs testing. The engineer generates validation protocols using templates and is responsible for protocol execution of various types of basic processing equipment under the direction of Validation Manger.

Role Responsibilities

• Determine process capability of new equipment through execution of approved protocols and assures defined parameters are incorporated into respective operating procedures and batch records.
• 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.

  Basic Qualifications

• BS in Chemistry, Biochemistry, Microbiology, Engineering, Pharmacy or related science; or equivalent combination of education and experience.
• 7+ years related validation experience and/or training.

  Preferred Qualifications

• 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.