Ai Pharmacist Jobs in Puerto Rico (NOW HIRING)

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:

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