Senior Validation Engineer

Kindeva Drug Delivery; St. Louis (MO); On-site; USD 80,000 - 110,000; Full time

Job summary

A leading company in drug delivery is seeking a Senior Validation Engineer to drive compliance and validation activities for manufacturing processes and equipment. The role requires an experienced professional capable of developing and executing validation protocols, ensuring adherence to regulatory standards, and contributing to continuous improvement efforts within the engineering team.

Qualifications

• 7+ years related validation experience.
• Ability to read and analyze technical documentation.
• Familiarity with regulatory guidance documents and validation processes.

Responsibilities

• Determine process capability of new equipment through approved protocols.
• Assist with validation activities from outside companies.
• Ensure compliance with industry standards and regulations.

Skills

Knowledge of cGMP

Ability to analyze and interpret scientific journals

Sound knowledge of pharmaceutical processing equipment

Education

BS in Chemistry, Biochemistry, Microbiology, Engineering, Pharmacy or related science

Job description

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.

Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.

Do you see yourself as part of the Kindeva mission? Click Apply Now Today!

• Job Family B - Engineering - Validation Engineering