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 ...
Quick apply
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 ...
PR · On-site
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards ...
New
Quick apply
PR · On-site
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards ...
New
PR · On-site
Its services include Engineering, Project Management, and Validation. MMR Consulting has offices in Canada, USA, and Australia. This is an outstanding opportunity to join our growing team, where the ...
Quick apply
PR · On-site
Its services include Engineering, Project Management, and Validation. MMR Consulting has offices in Canada, USA, and Australia. This is an outstanding opportunity to join our growing team, where the ...
PR · On-site
Its services include Engineering, Project Management, and Validation. MMR Consulting has offices in Canada, USA, and Australia. This is an outstanding opportunity to join our growing team, where the ...
PR · On-site
Its services include Engineering, Project Management, and Validation. MMR Consulting has offices in Canada, USA, and Australia. This is an outstanding opportunity to join our growing team, where the ...
PR · On-site
Its services include Engineering, Project Management, and Validation. MMRConsulting hasofficesinCanada,USA,andAustralia. This is an outstanding opportunity to join our growing team, where the ...
PR · On-site
Its services include Engineering, Project Management, and Validation. MMRConsulting hasofficesinCanada,USA,andAustralia. This is an outstanding opportunity to join our growing team, where the ...
PR · On-site
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards ...
Quick apply
PR · On-site
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards ...
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards ...
Quick apply
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards ...
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards ...
Quick apply
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards ...
PR · On-site
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards ...
Quick apply
PR · On-site
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards ...
PR · On-site
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards ...
Quick apply
PR · On-site
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards ...
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards ...
Quick apply
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards ...
PR · On-site
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards ...
Quick apply
PR · On-site
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards ...
PR · On-site
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards ...
Quick apply
PR · On-site
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards ...
PR · On-site
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards ...
Quick apply
PR · On-site
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards ...
PR · On-site
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards ...
Quick apply
PR · On-site
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards ...
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards ...
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards ...
Validation Specialist
Dorado, PR · On-site
For Validation services. WHAT MAKES YOU A FIT: The Technical Part: * Bachelor's in Engineering or ... Document management systems The Personality Part: * Our Next Piece is someone who treats everyone ...
Validation Specialist
Dorado, PR · On-site
For Validation services. WHAT MAKES YOU A FIT: The Technical Part: * Bachelor's in Engineering or ... Document management systems The Personality Part: * Our Next Piece is someone who treats everyone ...
Validation Specialist
Dorado, PR · On-site
For Validation services WHAT MAKES YOU A FIT: The Technical Part: * Bachelor's in Engineering with ... Document management systems The Personality Part: * Our Next Piece is someone who treats everyone ...
Validation Specialist
Dorado, PR · On-site
For Validation services WHAT MAKES YOU A FIT: The Technical Part: * Bachelor's in Engineering with ... Document management systems The Personality Part: * Our Next Piece is someone who treats everyone ...
PR · On-site
This role is fully on-site and will focus on the execution, documentation, and lifecycle management of cleaning validation activities for manufacturing equipment, utilities, and laboratory ...
Quick apply
PR · On-site
This role is fully on-site and will focus on the execution, documentation, and lifecycle management of cleaning validation activities for manufacturing equipment, utilities, and laboratory ...
PR · On-site
This role is fully on-site and will focus on the execution, documentation, and lifecycle management of cleaning validation activities for manufacturing equipment, utilities, and laboratory ...
Quick apply
PR · On-site
This role is fully on-site and will focus on the execution, documentation, and lifecycle management of cleaning validation activities for manufacturing equipment, utilities, and laboratory ...
Validation Manager information
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 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 is the difference between Validation Manager vs Quality Assurance Specialist?
| Aspect | Validation Manager | Quality Assurance Specialist |
|---|---|---|
| Certifications | GxP, ISO, or industry-specific validation certifications | ISO, Six Sigma, or QA-related certifications |
| Work Environment | Regulated industries like pharmaceuticals, biotech, or medical devices | Manufacturing, software, or service industries |
| Primary Focus | Ensuring validation processes for equipment, systems, and processes meet standards | Monitoring 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.
More about Validation Manager jobs
What are the most commonly searched types of Validation jobs in Puerto Rico?
The most popular types of Validation jobs in Puerto Rico are:
What are popular job titles related to Validation Manager jobs in Puerto Rico?
For Validation Manager jobs in Puerto Rico, the most frequently searched job titles are:
What job categories do people searching Validation Manager jobs in Puerto Rico look for?
The top searched job categories for Validation Manager jobs in Puerto Rico are:
What cities in Puerto Rico are hiring for Validation Manager jobs?
Cities in Puerto Rico with the most Validation Manager job openings:
Full-time
Medical, Dental, Vision
Re-posted 26 days ago
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