Senior Validation Engineer

Kindeva Drug Delivery Company; California (MO); On-site; USD 80,000 - 120,000; Full time

Job summary

Kindeva Drug Delivery Company seeks a Senior Validation Engineer to enhance product manufacturing equipment qualification and validation. This role involves developing protocols, executing validation activities, and ensuring compliance with industry standards in the pharmaceutical sector. The ideal candidate will possess strong expertise in validation processes and a relevant educational background.

Qualifications

• 7+ years of related validation experience and/or training required.

Responsibilities

• Determine process capability of new equipment through execution of approved protocols.
• Assist with validation activities performed by outside validation companies.
• Aid in compliance with contemporary industry standards and regulatory filings.

Skills

Knowledge of cGMP

Ability to interpret technical journals

Understanding of pharmaceutical processing equipment

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 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