Kindeva Drug Delivery · 19 hours ago
Senior Validation Manager
St Louis, MO
Full-time
Onsite
Senior Level, Lead/Staff
10+ years expKindeva Drug Delivery is a company that makes products that save lives, ensuring better health and well-being for patients around the world. The successful candidate will provide strategic and tactical support for equipment validation, lead a team of validation engineers, and ensure compliance with industry standards and regulatory requirements.
Manufacturing
Responsibilities
Support all product and process validation and equipment qualification at the site while following industry contemporary standards
Develop and maintain a Site Validation Master Plan and a Periodic Review program
Organize and lead the support of regulatory and internal audits as they relate to Validation and Change Management Program
SME for validation related topics during regulatory inspections, develop responses to potential findings, and assure timely completion of corrective actions and commitments
Responsible to keep all finished products, equipment, processes and facilities in compliance with contemporary industry standards and regulatory filings
Review and approve all proposed changes impacting finished products, equipment, processes and facilities
Ensure that all cleaning processes are qualified, and those products processes of being enhanced are validated appropriately
Develop and maintain a Cleaning Validation Master Plan
Responsible for resource projections and budget preparations
Responsible to provide or oversee the preparation of project cost estimates, and will provide support and GMP review for major site capital projects
Responsible for the development, mentoring, and performance management of a validation team
Qualification
Required
BS/MS or PhD in Chemistry, Biochemistry, Microbiology, Engineering, Pharmacy or related science
10+ years of related experience
Previous management experience (leading first line supervisors and managers preferred) including experience managing in at least several of the following: cGMPs, Regulatory (worldwide), deviation investigation, drug product lot release, GMP Audit support, technical product transfers, change control management, equipment qualification, cleaning validation, computerized systems validation, and product and process validation
A robust working comprehension of the theory and function of pharmaceutical equipment and systems is required. These may include sterilizers, depryrogenation ovens, washers, WFI, HVAC systems, aseptic filling equipment, incubators/refrigerators, cleaning equipment, inspection equipment, assembly equipment, labeling/packaging equipment, data recorders and personal computers
Knowledge of contemporary validation guidelines for pharmaceutical industry. Ability to read, analyze and interpret common scientific and technical journals, financial reports (as needed), and legal documents; comprehend equipment manuals and translate operational limits into protocols acceptance criteria; respond to regulatory agencies; and respond to complaints from customers
Ability to define problems, collect data, establish facts, and draw valid conclusions; interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract or concrete variables
Ability to gather and analyze information skillfully and present in many forms. Should have the ability to perform advanced mathematical concepts such as exponents, logarithms, quadratic equations (as needed), and apply mathematical operations to such tasks such as frequency distribution, CpK, determination of test reliability
Excellent verbal and written communication skills, with the ability to share vision, direction, and data with colleagues across all levels and in a wide range of different work groups
Demonstrated proficiency in organizational and project management skills and ability to balance multiple priorities
Advanced knowledge of Microsoft Office (Word, Excel, Outlook, Access, and Projects)
Company
Kindeva Drug Delivery
Kindeva Drug Delivery is a global contract development and manufacturing organization (CDMO) in the pharmaceutical industry.
1001-5000 employees
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 StageTotal Funding
$46.96MKey Investors
Global Britain Investment Fund
2023-08-03Grant· $41.96M
2022-11-14Acquired
2022-06-13Series Unknown· $5M
Leadership Team
Brian Schubmehl
Chief Human Resources Officer
Recent News
2026-01-16
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