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Validation Manager Jobs (NOW HIRING)

PR · On-site

Validation Manager About Ocyonbio: OcyonBio is a biotechnology CDMO based in Aguadilla, Puerto Rico, providing flexible cGMP facilities and integrated services to accelerate the development ...

Validation Manager

Corona, CA · On-site

$95K - $105K/yr

The Validation Manager works with Quality, Manufacturing, Maintenance, Sanitation, and Regulatory personnel to perform manufacturing process and cleaning process validations and qualification of ...

The Validation Manager works with Quality, Manufacturing, Maintenance, Sanitation, and Regulatory personnel to perform manufacturing process and cleaning process validations and qualification of ...

The team you manage performs Silicon validation on leading edge switch devices. Products use advanced Si technology nodes and advanced packaging, delivering the highest performance products in the ...

POSITION SUMMARY The Manager, Validation is responsible for being a hands-on leader to the validation staff as they perform qualification activities needed to meet company objectives. The role ...

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Validation Manager information

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$47.5K

$105.4K

$160.5K

How much do validation manager jobs pay per year?

As of Jun 28, 2026, the average yearly pay for validation manager in the United States is $105,415.00, according to ZipRecruiter salary data. Most workers in this role earn between $74,500.00 and $132,000.00 per year, depending on experience, location, and employer.

How does a Validation Manager typically collaborate with other departments during project execution?

Validation Managers frequently work cross-functionally with quality assurance, manufacturing, engineering, and regulatory teams to ensure all systems and processes meet required standards. Effective collaboration involves coordinating validation protocols, sharing critical documentation, and communicating status updates to keep projects on track. A Validation Manager often leads meetings to align stakeholders, addresses compliance concerns, and resolves issues swiftly to prevent delays. Building strong relationships across departments is essential for smooth validation processes and successful project outcomes.

What is the role of a validation manager?

A validation manager oversees the process of ensuring that products, processes, or systems meet specified requirements and quality standards. They develop validation protocols, coordinate testing activities, and ensure compliance with industry regulations, often working with quality assurance teams and utilizing validation tools. Their role is critical in industries like pharmaceuticals, manufacturing, and healthcare to ensure safety and efficacy.

What job makes $10,000 a month without a degree?

A Validation Manager typically earns a salary that can reach or exceed $10,000 per month, especially with experience and industry expertise. This role involves overseeing validation processes in industries like pharmaceuticals or manufacturing, often requiring strong technical skills and certifications but not necessarily a college degree.

What jobs in the US pay 300,000 a year?

Validation Managers in industries such as pharmaceuticals, biotechnology, and manufacturing can earn salaries approaching or exceeding $300,000 annually, especially with extensive experience, advanced certifications, and leadership responsibilities. High-level roles in finance, law, and executive management also frequently reach or surpass this salary level. Compensation varies based on location, company size, and individual expertise.

What Is a Validation Manager?

A validation manager works in a manufacturing plant and oversees the proper operation of machinery and equipment. Your job duties include developing operational plans for the entire facility, identifying areas of process improvement, and scheduling periodic auditing reviews of the facility. The qualifications needed for a career as a validation manager include a bachelor’s degree in business, organizational theory, quality control, or a related field. You also need strong communication and computer skills and experience in a management position.

What are the key skills and qualifications needed to thrive as a Validation Manager, and why are they important?

To thrive as a Validation Manager, you need a strong background in quality assurance, regulatory compliance (such as FDA or EMA guidelines), and validation principles, usually supported by a degree in life sciences or engineering. Familiarity with validation protocols, risk management tools, and systems like GMP documentation platforms is essential. Leadership, attention to detail, and effective communication are crucial soft skills for managing teams and coordinating cross-functional projects. These skills and qualities ensure that products and processes consistently meet regulatory standards, reducing risks and ensuring compliance.

What jobs pay 500,000 a year in the US?

Validation Managers typically do not earn $500,000 annually; such high salaries are more common in executive roles like CEOs, CFOs, or specialized high-level professionals in finance, law, or technology. Senior executives and certain specialized roles with significant responsibilities and experience can reach or exceed this income level, often including bonuses and stock options. Compensation varies widely based on industry, company size, and geographic location.

What is the difference between Validation Manager vs Quality Assurance Specialist?

AspectValidation ManagerQuality Assurance Specialist
CertificationsGxP, ISO, or industry-specific validation certificationsISO, Six Sigma, or QA-related certifications
Work EnvironmentRegulated industries like pharmaceuticals, biotech, or medical devicesManufacturing, software, or service industries
Primary FocusEnsuring validation processes for equipment, systems, and processes meet standardsMonitoring and improving overall quality processes and compliance

The Validation Manager primarily oversees validation activities to ensure compliance with industry standards, focusing on equipment and process validation. In contrast, the Quality Assurance Specialist concentrates on maintaining overall quality standards across products and services. Both roles are essential for compliance but differ in scope and responsibilities.

What are Validation Managers?

Validation Managers are professionals responsible for overseeing and managing the validation processes within an organization, particularly in industries like pharmaceuticals, biotechnology, and manufacturing. Their main role is to ensure that products, equipment, and processes meet regulatory standards and operate consistently as intended. They coordinate validation activities, develop protocols, lead teams, and ensure compliance with quality and safety regulations. Validation Managers play a critical role in maintaining product quality, reducing risks, and ensuring that all procedures meet industry and governmental standards.
What cities are hiring for Validation Manager jobs? Cities with the most Validation Manager job openings:
What are the most commonly searched types of Validation jobs? The most popular types of Validation jobs are:
Who are the top companies hiring for Validation Manager jobs? The top employers for Validation Manager jobs are:
What states have the most Validation Manager jobs? States with the most job openings for Validation Manager jobs include:
Infographic showing various Validation Manager job openings in the United States as of June 2026, with employment types broken down into 5% As Needed, 74% Full Time, 2% Part Time, 5% Temporary, 12% Contract, and 2% Nights. Highlights an 88% Physical, 4% Hybrid, and 8% Remote job distribution, with an average salary of $105,415 per year, or $50.7 per hour.

Validation Manager

Biosimilar Sciences PR LLC

PR • On-site

Full-time

Medical, Dental, Vision

This job post has expired 2 days ago. Applications are no longer accepted.


Job description


Job Title: Validation Manager


About Ocyonbio:

OcyonBio is a biotechnology CDMO based in Aguadilla, Puerto Rico, providing flexible cGMP facilities and integrated services to accelerate the development, manufacturing, and commercialization of biologics, cell & gene therapies, and advanced pharmaceutical products. Operating as a cGMP incubator-style environment, OcyonBio enables robust CMC data generation to support global regulatory submissions. We are committed to fostering an inclusive, respectful workplace where integrity, collaboration, and technical excellence are core to everything we do.


Place of Performance: CII George Sanders, Aguadilla Pueblo, Aguadilla P.R. 00603.

Job Overview:

OcyonBio is seeking a Validation Manager to establish, lead, and govern the site Validation Program, including full ownership of the Site Master Validation Plan (SMVP). This role is responsible for ensuring that facilities, utilities, and manufacturing equipment are initially qualified, periodically requalified, and maintained in a validated state throughout their lifecycle in a multi-client CDMO environment.

The Validation Manager provides both hands-on technical leadership and strategic oversight, leading teams of company employees and contract personnel, and serving as the validation subject matter expert during regulatory inspections and client audits.

The Validation Manager is also expected to actively and continuously leverage AI-enabled tools and digital technologies to improve validation planning, execution, documentation quality, trend analysis, and inspection readiness, while ensuring full compliance with cGMP and data integrity requirements.


Key Responsibilities:

Validation Program & Governance

  • Establish, lead, and maintain the sitewide Validation Program
  • Develop, approve, and govern the Site Master Validation Plan (SMVP)
  • Ensure lifecycle validation control from design and commissioning through operation, requalification, and decommissioning
  • Coordinate initial qualification, periodic requalification, and change-driven revalidation activities

Facility & Utility Qualification

  • Lead validation and qualification of:
    • Cleanrooms and HVAC systems
    • WFI, purified water, clean steam, and compressed gas systems
    • Environmental monitoring systems
  • Implement risk-based commissioning and qualification (C&Q) approaches in accordance with ASTM E2500 and ISPE guidelines
  • Ensure facility systems remain in a validated state and inspection-ready

Equipment Startup & Qualification

  • Direct startup, commissioning, and qualification of critical manufacturing and laboratory equipment, including:
    • Sterile filling lines, autoclaves, incubators, refrigerators, and freezers
    • Bioreactors, chromatography skids, and single-use systems (SUS)
    • Solid dosage equipment (granulators, tablet presses, coating systems)
  • Oversee FAT/SAT planning and execution
  • Approve IQ/OQ/PQ protocols, reports, and traceability matrices

Team & Resource Leadership

  • Lead validation activities performed by company employees and contract validation personnel
  • Build, train, and manage validation resources to support project and operational needs
  • Oversee vendor qualification and validation service providers

Digital Enablement & AI Utilization

  • Consistently use AI-enabled tools to enhance validation lifecycle activities, including protocol development, risk assessments, deviation analysis, trend identification, and continuous improvement
  • Apply AI tools to improve efficiency, consistency, and quality of validation documentation and data review
  • Ensure responsible and compliant use of AI technologies in alignment with cGMP, data integrity (21 CFR Part 11), and company policies
  • Identify and implement opportunities for AI and automation to strengthen validation processes while maintaining regulatory compliance

Compliance & Inspection Readiness

  • Ensure compliance with FDA, EMA, MHRA, WHO, and ICH Q7–Q10 requirements
  • Serve as Validation SME during regulatory inspections and client audits
  • Lead deviation investigations, impact assessments, and CAPAs related to validation activities
  • Ensure data integrity compliance, including 21 CFR Part 11

Cross-Functional Collaboration

  • Partner with Engineering, Facilities, Quality, Manufacturing, and external vendors to ensure seamless project execution
  • Support technology transfers, facility expansions, and new client onboarding
  • Train operations and quality personnel on validation expectations, procedures, and digital tools


Qualifications:

Education & Experience

  • Bachelor’s degree in Engineering, Biotechnology, Pharmaceutical Sciences, or related discipline
  • 5+ years of progressive validation experience in pharmaceutical, biotech, or CDMO environments
  • Demonstrated experience leading site-level validation programs and supporting regulatory inspections


Technical Expertise

  • Cleanroom and critical utility qualification
  • Aseptic processing and sterilization validation
  • Equipment commissioning and lifecycle validation
  • Risk-based validation (ASTM E2500)
  • Familiarity with automation systems (PLC/SCADA), ISPE Baseline Guides, and data integrity requirements
  • Demonstrated ability and willingness to continuously adopt and use AI-enabled tools in GxP-regulated environments


Leadership & Soft Skills

  • Strong technical writing and documentation skills
  • Excellent problem-solving and decision-making abilities
  • Effective communicator with strong cross-functional collaboration skills
  • Ability to lead in a fast-paced, multi-client CDMO environment


Preferred Qualifications

  • Lean Six Sigma, ASQ CQE, or ISPE certification
  • Experience with EU GMP Annex 1 (Sterility Assurance)
  • Hands-on exposure to single-use bioprocessing and viral vector manufacturing
  • Experience implementing or using AI tools within regulated GxP environments


Working Conditions

  • Work in classified cleanroom environments with aseptic gowning
  • Travel may be required for FAT/SAT, vendor audits, and client engagements
  • Flexibility to support extended hours or weekends during critical validation phases

What we offer:

  • Competitive compensation and benefits
  • Health, dental, and vision insurance
  • Professional training and development opportunities
  • Eligibility for company stock option programs
  • Opportunity to help build and shape a growing CDMO


We Are An Equal Opportunity Employer
Ocyonbio provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity, or expression, or any other characteristic protected by federal, state or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

To learn more about us, please visit our website: https://ocyonbio.com