KD
Senior Validation Engineer
full-time•St. Louis
About this role
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 Aseptic product manufacturing equipment qualification/validation, Cleaning Validation & Process validation protocols and perform testing and write validation reports.
Role Responsibilities:
- Generate validation protocols using templates.
- 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.
- 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.
Qualifications
- Bachelor’s degree in Chemistry, Biochemistry, Microbiology, Engineering, Pharmacy or related science.
- 7+ years related experience and/or training, or equivalent combination of education and experience.
- 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.
#LI-ON-SITE
California residents should review our Notice for California Employees and Applicants before applying.
Kindeva does not accept unsolicited assistance from headhunters or recruitment firms for any of our job openings. Any resumes or candidate profiles submitted to Kindeva employees—regardless of format—without a valid, signed agreement and an approved job order from an authorized signatory in Talent Acquisition will be considered the sole property of Kindeva. No fees will be paid in the event that a candidate is hired as a result of an unsolicited resume or referral.
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.
Do you see yourself as part of the Kindeva mission? Click Apply Now Today!
What you'll do
- The Senior Validation Engineer will assist in developing Aseptic product manufacturing equipment qualification/validation, Cleaning Validation, and Process validation protocols, executing testing, and writing validation reports. Responsibilities include generating protocols, executing testing on processing equipment under supervision, and issuing related reports and memos.
About Kindeva Drug Delivery
Kindeva is a global powerhouse CDMO dedicated to manufacturing more tomorrows. Leveraging more than 100 years of innovation, Kindeva provides unrivaled expertise at every stage of pulmonary, nasal, injectable, intradermal, and transdermal therapy development and manufacturing. Whether providing holistic analytical support or scaling sterile injectable fill-finish operations, every solution is backed by extensive technological capabilities, deep regulatory knowledge, and state-of-the-art facilities across the U.S. and U.K. Kindeva’s proactive, informed solutions minimize risk and maximize confidence from ideation through commercialization, bringing high-quality products to patients in need, faster. For more information about our leading drug-device CDMO, please visit www.kindevadd.com.
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Frequently Asked Questions
What does a Senior Validation Engineer do at Kindeva Drug Delivery?
As a Senior Validation Engineer at Kindeva Drug Delivery, you will: the Senior Validation Engineer will assist in developing Aseptic product manufacturing equipment qualification/validation, Cleaning Validation, and Process validation protocols, executing testing, and writing validation reports. Responsibilities include generating protocols, executing testing on processing equipment under supervision, and issuing related reports and memos..
Is the Senior Validation Engineer position at Kindeva Drug Delivery remote?
The Senior Validation Engineer position at Kindeva Drug Delivery is based in St. Louis, Missouri, United States. Contact the company through Clera for specific work arrangement details.
How do I apply for the Senior Validation Engineer position at Kindeva Drug Delivery?
You can apply for the Senior Validation Engineer position at Kindeva Drug Deliverydirectly through Clera. Click the "Apply Now" button above to start your application. Clera's AI-powered platform will help match your profile with this opportunity and guide you through the application process.