Validation Engineer

Kindeva Drug Delivery; St. Louis (MO); On-site; USD 70,000 - 95,000; Full time

Job summary

Kindeva Drug Delivery is seeking a Validation Engineer to assist in the qualification and validation of manufacturing equipment. Applicants should possess a BS in a related science with significant validation experience. This role includes protocol execution and compliance with regulatory standards, ensuring high-quality manufacturing practices.

Qualifications

• 3+ years related validation experience and/or training.
• Ability to read and interpret scientific and technical documents.

Responsibilities

• Execute protocols for basic processing equipment.
• Determine process capability of new equipment.
• Assist with compliance to industry standards.

Skills

Knowledge of cGMP

Analytical Skills

Technical Writing

Education

BS in Chemistry, Biochemistry, Microbiology, Engineering, Pharmacy

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 Validation Engineer will assist in the development of inspection, assembly and packaging product manufacturing equipment qualification/validation, process validation protocols, 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 Manager.

Role Responsibilities

• Responsible for protocol execution of basic processing equipment including (but not limited to) the following: Manufacturing Facilities, Inspection Equipment, Assembly Equipment, Packaging Equipment andRefrigerators (cold storge).
• Assist 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.
• 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.
• 3+ 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.

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