Validation Quality Engineer

Posted Thursday, January 4, 2024 at 5 : 00 AM

A variety of soft skills and experience may be required for the following role Please ensure you check the overview below carefully.

ROLE SUMMARY :

Kindeva is a leading global contract developer and manufacturer (CDMO) with delivery platform expertise in Autoinjector, Inhalation, Transdermal / Intradermal Patch Technologies.

We partner with our customers to improve patient outcomes around the world. Together, as One Team, we will manufacture many more tomorrows.

Ready to work with purpose? Look no further, we are hiring for a Validation Quality Engineer to join our St. Louis Missouri team!

This position is for an individual contributor to the Quality Operations Validation department.

The successful candidate will assist in the development of assembly and packaging validation protocols, perform testing, and write validation reports for various equipment.

Generate validation protocols using templates. Responsible for protocol execution of various types of basic processing equipment under the direction of Validation Manager.

ROLE RESPONSIBILITIES :

• Assists with development of assembly and packaging validation protocols, perform testing and write validation reports for various equipment.
• Generate validation protocols using templates.
• Primary responsible for 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.
• Perform special projects as assigned by department manager.
• 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.

EDUCATION & EXPERIENCE :

At a minimum, the successful candidate must have a high school diploma and 0 to 3 years related experience and / or training;

or equivalent combination of education and experience.

PREFERRED QUALIFICATIONS :

• Bachelor’s degree in Chemistry, Biochemistry, Microbiology, Engineering, Pharmacy or related science.
• Knowledge of cGMP and internal SOPs and general knowledge of associated industry and regulatory guidance documents.
• 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.

To perform this job successfully, an individual should have working knowledge of Microsoft Office (Word, Excel, Outlook, Access, and Projects).

Safety for our employees and our communities is a key priority for Kindeva Drug Delivery. Kindeva encourages everyone who can get vaccinated to get vaccinated.

Our Covid-19 task force monitors the external environment and will continue to evaluate our policies and procedures.

Equal Opportunity Employer :

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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