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A R Director Jobs in Puerto Rico (NOW HIRING)

Biosimilar Sciences PR LLC

PR · On-site

  • Medical

  • Dental

  • Vision

R. 00603. Job Overview: OcyonBio is seeking a Validation Manager to establish, lead, and govern the ... Direct startup, commissioning, and qualification of critical manufacturing and laboratory equipment ...

Biosimilar Sciences PR LLC

PR · On-site

$16.75 - $21.75/hr

  • Medical

  • Dental

  • Vision

R. 00603. Job Overview: Cleanroom Sanitation Team Lead will play a critical role in the start-up ... Direct experience supporting cleaning and sanitation activities in classified areas. * Strong ...

Biosimilar Sciences PR LLC

PR · On-site

$18.50 - $25.50/hr

  • Medical

  • Dental

  • Vision

Maintenance Specialist Company: OcyonBio is a partnership development and manufacturing ... R. 00603. Job Overview The Maintenance Specialist is responsible for maintenance and calibration ...

Jj

External Manufacturing Program Manager

Guaynabo, PR · On-site

  • Retirement

  • PTO

R-085712 Remember, whether you apply to one or all of these requisition numbers, your applications ... A minimum of 5 years relevant experience. * Demonstrated direct or indirect people management ...

Cencora

Manufacturing Engineer II

Humacao, PR · On-site

$73K - $95K/yr

  • Medical

  • Dental

  • Vision

May act as a mentor to colleagues or may direct the work of other lower level professionals. Responsibilities: * Designs manufacturing processes, procedures and production layouts for assemblies ...

ABB

Global Product Manager - Transformers

Aguadilla, PR · On-site +1

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

If remote, candidates should be located near a major metro area. This role is contributing to the ... Translate customer insights into product and portfolio direction through direct engagement with ...

New

Kelly Services

PR

$65/hr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

We're seeking a Sr Packaging Engineer to work at a leading biotech organization in Gurabo, PR . ... Bilingual in English and Spanish The Sr Packaging Engineer- Primary Container Technical Owne r will ...

New

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All JobsA R JobsA R Director JobsA R Director Jobs in Puerto Rico

A R Director information

What is the difference between A R Director vs Accounts Receivable Manager?

AspectA R DirectorAccounts Receivable Manager
ResponsibilitiesOversees the entire accounts receivable department, develops policies, manages teams, and ensures cash flow optimization.Manages daily receivables, processes invoices, and handles collections within the department.
Required CredentialsBachelor's degree in finance, accounting, or related field; extensive experience in AR; leadership skills.Bachelor's degree in accounting or finance; experience in AR and collections.
Work EnvironmentCorporate finance departments, often in larger organizations or multinational companies.Finance or accounting departments, typically in mid-sized to large companies.

The main difference is that an A R Director has a strategic, leadership role overseeing the entire AR function, while an Accounts Receivable Manager handles daily operations and collections. The director focuses on policy, process improvement, and team management, whereas the manager concentrates on executing tasks and managing receivables on a day-to-day basis.

What are the most commonly searched types of A R jobs in Puerto Rico? The most popular types of A R jobs in Puerto Rico are:
What are popular job titles related to A R Director jobs in Puerto Rico? For A R Director jobs in Puerto Rico, the most frequently searched job titles are:
What job categories do people searching A R Director jobs in Puerto Rico look for? The top searched job categories for A R Director jobs in Puerto Rico are:
What cities in Puerto Rico are hiring for A R Director jobs? Cities in Puerto Rico with the most A R Director job openings:
A R Director jobs near you
Infographic showing various A R Director job openings in Puerto Rico as of August 2026, with employment types broken down into 1% As Needed, 83% Full Time, 12% Part Time, 3% Temporary, and 1% Contract. Highlights an 93% Physical, 3% Hybrid, and 4% Remote job distribution.

Validation Manager

Biosimilar Sciences PR LLC

PR • On-site

Full-time

Medical, Dental, Vision

Re-posted 22 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