Senior Validation Engineer jobs in United States
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Kindeva Drug Delivery · 20 hours ago

Senior Validation Engineer

Kindeva Drug Delivery is a company that makes products to save lives, ensuring better health and well-being for patients globally. The Senior Validation Engineer will assist in the development of aseptic product manufacturing equipment qualification and validation, including cleaning and process validation protocols, while performing testing and writing validation reports.

Manufacturing
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H1B Sponsor Likelynote

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

Qualification

CGMP knowledgePharmaceutical processing equipmentBachelor’s degree in scienceValidation protocolsAnalytical skills

Required

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

Company

Kindeva Drug Delivery

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Kindeva Drug Delivery is a global contract development and manufacturing organization (CDMO) in the pharmaceutical industry.

H1B Sponsorship

Kindeva Drug Delivery has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (4)
2023 (1)
2022 (3)

Funding

Current Stage
Late Stage
Total Funding
$46.96M
Key Investors
Global Britain Investment Fund
2023-08-03Grant· $41.96M
2022-11-14Acquired
2022-06-13Series Unknown· $5M

Leadership Team

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Brian Schubmehl
Chief Human Resources Officer
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Company data provided by crunchbase