Albion Rye Associates · 6 hours ago
Director of Validation - CDMO
United States
Full-time
Remote
Director/Executive
$200K/yr - $200K/yr
10+ years exp
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Hiring Manager
Jake Byrne - Albion Rye Associates
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Responsibilities
Lead and manage the Validation department, including validation engineers and specialists.
Oversee the creation and execution of validation protocols for equipment, systems, processes, and cleaning methods.
Ensure all validation activities are compliant with cGMP, FDA, and other applicable regulatory requirements.
Develop and maintain validation master plans and related documentation.
Review and approve validation documentation, including protocols, reports, and deviations.
Collaborate with other departments (e.g., Quality, Manufacturing, Regulatory Affairs) to support project timelines and operational objectives.
Provide leadership and guidance on validation strategies for new product introductions and process improvements.
Manage and report on validation-related KPIs, ensuring projects are completed on time and within budget.
Stay up-to-date with industry trends, regulations, and best practices related to validation.
Qualification
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Required
Bachelor’s degree in Engineering, Life Sciences, or a related field
Minimum of 10 years of experience in validation within the pharmaceutical or biotechnology industry, with at least 5 years in a leadership role
In-depth knowledge of FDA and international regulatory requirements, cGMP, and industry standards
Strong experience in equipment, facility, and process validation, including qualification/validation protocols and reports
Excellent leadership, communication, and interpersonal skills
Ability to manage multiple priorities and work effectively in a fast-paced, team-oriented environment
Preferred
Advanced degree preferred
Benefits
Relocation support
Comprehensive health, dental, and vision insurance
Retirement plan options
Paid time off and holidays
Professional development opportunities
Company
Albion Rye Associates
Albion Rye Associates are global single sector, life sciences recruitment experts, dedicated to supporting clients in their mission to positively impact, and improve patient lives globally.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase
