PR · On-site
Direct startup, commissioning, and qualification of critical manufacturing and laboratory equipment ... Oversee vendor qualification and validation service providers Digital Enablement & AI Utilization
Quick apply
PR · On-site
Direct startup, commissioning, and qualification of critical manufacturing and laboratory equipment ... Oversee vendor qualification and validation service providers Digital Enablement & AI Utilization
Review standard recipes, portion control, yields, and pricing to ensure proper margins. * Verify ... Verifies contracts for groups and performs credit reference checks for direct billed groups if ...
Sales Lead - Soma
San Juan, PR · On-site
... directed by Management. * Develops a high-performance culture, motivating sales team to meet ... Ensures team maintains consistent client communication through utilization of customer book ...
Sales Lead - Soma
San Juan, PR · On-site
... directed by Management. * Develops a high-performance culture, motivating sales team to meet ... Ensures team maintains consistent client communication through utilization of customer book ...
Sales Lead - Chico's
San Juan, PR · On-site
... directed by Management. * Develops a high-performance culture, motivating sales team to meet ... Ensures team maintains consistent client communication through utilization of customer book ...
Sales Lead - Chico's
San Juan, PR · On-site
... directed by Management. * Develops a high-performance culture, motivating sales team to meet ... Ensures team maintains consistent client communication through utilization of customer book ...
Financial Controller
San Juan, PR · Hybrid
Review financial results, validate accuracy, and investigate material variances vs. budget and ... Partner with regional finance and leadership to forecast cash needs and optimize cash utilization ...
New
Financial Controller
San Juan, PR · Hybrid
Review financial results, validate accuracy, and investigate material variances vs. budget and ... Partner with regional finance and leadership to forecast cash needs and optimize cash utilization ...
New
Sales Lead - Soma
San Juan, PR · On-site
... directed by Management. * Develops a high-performance culture, motivating sales team to meet ... Ensures team maintains consistent client communication through utilization of customer book ...
Sales Lead - Soma
San Juan, PR · On-site
... directed by Management. * Develops a high-performance culture, motivating sales team to meet ... Ensures team maintains consistent client communication through utilization of customer book ...
... directed by Management. * Develops a high-performance culture, motivating sales team to meet ... Ensures team maintains consistent client communication through utilization of customer book ...
... directed by Management. * Develops a high-performance culture, motivating sales team to meet ... Ensures team maintains consistent client communication through utilization of customer book ...
Cost Control Manager
Dorado, PR · On-site
Review standard recipes, portion control, yields, and pricing to ensure proper margins. * Verify ... Verifies contracts for groups and performs credit reference checks for direct billed groups if ...
Cost Control Manager
Dorado, PR · On-site
Review standard recipes, portion control, yields, and pricing to ensure proper margins. * Verify ... Verifies contracts for groups and performs credit reference checks for direct billed groups if ...
Financial Controller
San Juan, PR · Hybrid
Review financial results, validate accuracy, and investigate material variances vs. budget and ... Partner with regional finance and leadership to forecast cash needs and optimize cash utilization ...
New
Financial Controller
San Juan, PR · Hybrid
Review financial results, validate accuracy, and investigate material variances vs. budget and ... Partner with regional finance and leadership to forecast cash needs and optimize cash utilization ...
New
Financial Controller
San Juan, PR · Hybrid
Review financial results, validate accuracy, and investigate material variances vs. budget and ... Partner with regional finance and leadership to forecast cash needs and optimize cash utilization ...
New
Financial Controller
San Juan, PR · Hybrid
Review financial results, validate accuracy, and investigate material variances vs. budget and ... Partner with regional finance and leadership to forecast cash needs and optimize cash utilization ...
New
... directed by Management. * Develops a high-performance culture, motivating sales team to meet ... Ensures team maintains consistent client communication through utilization of customer book ...
... directed by Management. * Develops a high-performance culture, motivating sales team to meet ... Ensures team maintains consistent client communication through utilization of customer book ...
Cost Control Manager
Dorado, PR · On-site
Review standard recipes, portion control, yields, and pricing to ensure proper margins. * Verify ... direct billed groups if necessary. Maintaining Finance and Accounting Goals • Achieves and ...
Cost Control Manager
Dorado, PR · On-site
Review standard recipes, portion control, yields, and pricing to ensure proper margins. * Verify ... direct billed groups if necessary. Maintaining Finance and Accounting Goals • Achieves and ...
Conduct monthly performance reviews * Recognize talented staff and develop them for growth within ... Genesco's employment practices will continue to be directed toward full utilization of all ...
Conduct monthly performance reviews * Recognize talented staff and develop them for growth within ... Genesco's employment practices will continue to be directed toward full utilization of all ...
Conduct monthly performance reviews * Recognize talented staff and develop them for growth within ... Genesco's employment practices will continue to be directed toward full utilization of all ...
Conduct monthly performance reviews * Recognize talented staff and develop them for growth within ... Genesco's employment practices will continue to be directed toward full utilization of all ...
Conduct monthly performance reviews * Recognize talented staff and develop them for growth within ... Genesco's employment practices will continue to be directed toward full utilization of all ...
Conduct monthly performance reviews * Recognize talented staff and develop them for growth within ... Genesco's employment practices will continue to be directed toward full utilization of all ...
Conduct monthly performance reviews * Recognize talented staff and develop them for growth within ... Genesco's employment practices will continue to be directed toward full utilization of all ...
Conduct monthly performance reviews * Recognize talented staff and develop them for growth within ... Genesco's employment practices will continue to be directed toward full utilization of all ...
Conduct monthly performance reviews * Recognize talented staff and develop them for growth within ... Genesco's employment practices will continue to be directed toward full utilization of all ...
Store Manager Puerto Rico
Mayaguez, PR · On-site
Conduct monthly performance reviews * Recognize talented staff and develop them for growth within ... Genesco's employment practices will continue to be directed toward full utilization of all ...
Store Manager Puerto Rico
Mayaguez, PR · On-site
Conduct monthly performance reviews * Recognize talented staff and develop them for growth within ... Genesco's employment practices will continue to be directed toward full utilization of all ...
Store Manager Puerto Rico
Barceloneta, PR · On-site
Conduct monthly performance reviews * Recognize talented staff and develop them for growth within ... Genesco's employment practices will continue to be directed toward full utilization of all ...
Store Manager Puerto Rico
Barceloneta, PR · On-site
Conduct monthly performance reviews * Recognize talented staff and develop them for growth within ... Genesco's employment practices will continue to be directed toward full utilization of all ...
Conduct monthly performance reviews * Recognize talented staff and develop them for growth within ... Genesco's employment practices will continue to be directed toward full utilization of all ...
Utilization Review Director information
What is the difference between Utilization Review Director vs Utilization Review Nurse?
| Aspect | Utilization Review Director | Utilization Review Nurse |
|---|---|---|
| Credentials | RN license, management experience, certifications (e.g., CCM) | RN license, certification in case management or utilization review (e.g., CUC) |
| Work Environment | Administrative, leadership roles overseeing teams | Clinical, review of patient cases, direct patient care |
| Employer & Industry | Hospitals, insurance companies, healthcare organizations | Hospitals, insurance companies, healthcare providers |
| Search & Comparison Intent | Leadership, management, strategic planning in utilization review | Clinical review, case assessment, patient care coordination |
The Utilization Review Director typically oversees review teams and manages utilization strategies, requiring leadership skills and management experience. In contrast, the Utilization Review Nurse focuses on clinical case assessments and patient care reviews. Both roles require RN licensure and relevant certifications but differ mainly in scope and responsibilities.
What does a Utilization Review Director do?
A Utilization Review Director oversees the evaluation of medical necessity, appropriateness, and efficiency of healthcare services provided to patients. They lead teams that review patient care requests, manage compliance with regulations, and implement strategies to ensure cost-effective care without compromising quality. Their responsibilities often include policy development, data analysis, and collaboration with healthcare providers to optimize resource use and improve patient outcomes.
What are some common challenges faced by a Utilization Review Director, and how can they be addressed?
A Utilization Review Director often navigates challenges such as balancing regulatory compliance with organizational goals, managing interdisciplinary teams, and keeping up with evolving healthcare policies. Staying proactive with ongoing education, fostering open communication among staff, and implementing efficient review processes can help address these issues. Additionally, leveraging data analytics and technology streamlines case reviews and ensures evidence-based decision-making, ultimately improving both patient outcomes and operational efficiency.
What are the key skills and qualifications needed to thrive as a Utilization Review Director, and why are they important?
To thrive as a Utilization Review Director, you need a deep understanding of clinical guidelines, healthcare regulations, and case management principles, typically supported by a nursing or related healthcare degree and relevant licensure. Familiarity with utilization management software, electronic health records (EHR), and certifications such as Certified Case Manager (CCM) or Accredited Case Manager (ACM) is common in the field. Strong leadership, communication, analytical thinking, and decision-making skills help you effectively manage teams and ensure compliance. These competencies ensure efficient resource use, regulatory adherence, and high-quality patient outcomes within healthcare organizations.
What are the most commonly searched types of Utilization Review jobs in Puerto Rico? The most popular types of Utilization Review jobs in Puerto Rico are:
Full-time
Medical, Dental, Vision
Posted 25 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