PR · On-site
Direct startup, commissioning, and qualification of critical manufacturing and laboratory equipment ... Build, train, and manage validation resources to support project and operational needs * Oversee ...
Quick apply
PR · On-site
Direct startup, commissioning, and qualification of critical manufacturing and laboratory equipment ... Build, train, and manage validation resources to support project and operational needs * Oversee ...
Delegates tasks to all direct patient care staff including but not limited to LVN/LPNs, Patient ... Educates patients regarding laboratory values and the relationship to adequate dialysis therapy ...
Delegates tasks to all direct patient care staff including but not limited to LVN/LPNs, Patient ... Educates patients regarding laboratory values and the relationship to adequate dialysis therapy ...
Delegates tasks to all direct patient care staff including but not limited to LVN/LPNs, Patient ... Educates patients regarding laboratory values and the relationship to adequate dialysis therapy ...
Delegates tasks to all direct patient care staff including but not limited to LVN/LPNs, Patient ... Educates patients regarding laboratory values and the relationship to adequate dialysis therapy ...
Delegates tasks to all direct patient care staff including but not limited to LVN/LPNs, Patient ... Educates patients regarding laboratory values and the relationship to adequate dialysis therapy ...
Delegates tasks to all direct patient care staff including but not limited to LVN/LPNs, Patient ... Educates patients regarding laboratory values and the relationship to adequate dialysis therapy ...
Delegates tasks to all direct patient care staff including but not limited to LVN/LPNs, Patient ... Educates patients regarding laboratory values and the relationship to adequate dialysis therapy ...
Delegates tasks to all direct patient care staff including but not limited to LVN/LPNs, Patient ... Educates patients regarding laboratory values and the relationship to adequate dialysis therapy ...
... operational experience. Key Responsibilities Perform emergency medical treatment for Sailors ... Direct enlistment into the Hospital Corpsman rating from civilian life; in service conversion for ...
... operational experience. Key Responsibilities Perform emergency medical treatment for Sailors ... Direct enlistment into the Hospital Corpsman rating from civilian life; in service conversion for ...
... operational experience. Key Responsibilities Perform emergency medical treatment for Sailors ... Direct enlistment into the Hospital Corpsman rating from civilian life; in service conversion for ...
... operational experience. Key Responsibilities Perform emergency medical treatment for Sailors ... Direct enlistment into the Hospital Corpsman rating from civilian life; in service conversion for ...
... operational experience. Key Responsibilities Perform emergency medical treatment for Sailors ... Direct enlistment into the Hospital Corpsman rating from civilian life; in service conversion for ...
... operational experience. Key Responsibilities Perform emergency medical treatment for Sailors ... Direct enlistment into the Hospital Corpsman rating from civilian life; in service conversion for ...
... operational experience. Key Responsibilities Perform emergency medical treatment for Sailors ... Direct enlistment into the Hospital Corpsman rating from civilian life; in service conversion for ...
... operational experience. Key Responsibilities Perform emergency medical treatment for Sailors ... Direct enlistment into the Hospital Corpsman rating from civilian life; in service conversion for ...
... operational experience. Key Responsibilities Perform emergency medical treatment for Sailors ... Direct enlistment into the Hospital Corpsman rating from civilian life; in service conversion for ...
... operational experience. Key Responsibilities Perform emergency medical treatment for Sailors ... Direct enlistment into the Hospital Corpsman rating from civilian life; in service conversion for ...
... operational experience. Key Responsibilities Perform emergency medical treatment for Sailors ... Direct enlistment into the Hospital Corpsman rating from civilian life; in service conversion for ...
... operational experience. Key Responsibilities Perform emergency medical treatment for Sailors ... Direct enlistment into the Hospital Corpsman rating from civilian life; in service conversion for ...
... operational experience. Key Responsibilities Perform emergency medical treatment for Sailors ... Direct enlistment into the Hospital Corpsman rating from civilian life; in service conversion for ...
... operational experience. Key Responsibilities Perform emergency medical treatment for Sailors ... Direct enlistment into the Hospital Corpsman rating from civilian life; in service conversion for ...
... operational experience. Key Responsibilities Perform emergency medical treatment for Sailors ... Direct enlistment into the Hospital Corpsman rating from civilian life; in service conversion for ...
... operational experience. Key Responsibilities Perform emergency medical treatment for Sailors ... Direct enlistment into the Hospital Corpsman rating from civilian life; in service conversion for ...
Board Certified Behavior Analyst / BCBA
San Juan, PR · On-site
$85K/yr
... Autism Research Laboratory at Temple University * Industry Recognition - Proudly named in Inc ... Whether your passion is direct clinical impact, leadership, process improvement, or innovation, we ...
Quick apply
Board Certified Behavior Analyst / BCBA
San Juan, PR · On-site
$85K/yr
... Autism Research Laboratory at Temple University * Industry Recognition - Proudly named in Inc ... Whether your passion is direct clinical impact, leadership, process improvement, or innovation, we ...
$17/hr
... operations are well coordinated between each function. * Operate laboratory equipment such as ... Requests for accommodation related to our application process can be directed to the Kelly Human ...
Quick apply
$17/hr
... operations are well coordinated between each function. * Operate laboratory equipment such as ... Requests for accommodation related to our application process can be directed to the Kelly Human ...
Director Laboratory Operations information
What is a director laboratory operations?
A Director of Laboratory Operations oversees the daily functions, strategic planning, and overall efficiency of a laboratory. They are responsible for ensuring compliance with regulations, managing budgets, and coordinating staff to maintain high-quality standards. This role often involves optimizing workflows, implementing new technologies, and collaborating with leadership to support research or clinical objectives. Strong leadership, problem-solving, and laboratory management experience are essential for success in this position.
What are the typical career advancement opportunities for someone in a director laboratory operations role?
A Director Laboratory Operations can pursue advancement to executive roles such as Vice President of Laboratory Services, Chief Operating Officer, or even Chief Scientific Officer, depending on the organization’s structure. This role provides valuable leadership experience and exposure to high-level strategy, budgeting, and cross-departmental collaboration. Many directors also expand their expertise by leading larger teams, overseeing multiple laboratory sites, or participating in organizational growth initiatives. Continued professional development and success in this position often open doors to significant influence on company direction and industry innovation.
What are the key skills and qualifications needed to thrive in the director laboratory operations position, and why are they important?
To excel as a Director Laboratory Operations, you need strong leadership abilities, extensive experience in laboratory management, and an advanced degree in a scientific or technical field. Familiarity with laboratory information management systems (LIMS), regulatory compliance standards (such as CLIA, CAP, or ISO), and safety protocols is crucial. Excellent communication, strategic thinking, and problem-solving skills distinguish top performers in this role. These competencies ensure efficient laboratory operations, regulatory adherence, and effective team leadership in a complex and fast-paced environment.
What are the most commonly searched types of Laboratory Operations jobs in Puerto Rico?
The most popular types of Laboratory Operations jobs in Puerto Rico are:
What job categories do people searching Director Laboratory Operations jobs in Puerto Rico look for?
The top searched job categories for Director Laboratory Operations jobs in Puerto Rico are:
What cities in Puerto Rico are hiring for Director Laboratory Operations jobs?
Cities in Puerto Rico with the most Director Laboratory Operations job openings:
Full-time
Medical, Dental, Vision
Re-posted 27 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