Validation Manager

Job Title: Validation Manager

About Ocyonbio:

Ocyonbio is a biotechnology company based in Aguadilla, Puerto Rico, dedicated to propelling the future of healthcare. We provide cGMP spaces that can be customized to meet unique requirements and services to help catalyze the development, manufacturing, and commercialization of biologics, genetic, and cellular therapies. We behave more like a cGMP incubator space with all regulatory, systems capabilities, and resources to enable CMC data to support regulatory applications.

We strive to create a space free of both explicit and implicit discrimination and harassment where everyone feels safe, heard, and valued. The character of our employees is as important as their talent, and we are proud of the team and environment we are assembling as we grow.

Place of Performance: CII George Sanders, Aguadilla Pueblo, Aguadilla P.R. 00603.

Job Overview:

We are seeking an experienced Validation Manager to join our dynamic team. The Validation Manager will oversee the development and implementation of validation processes for our equipment, facilities, utilities, systems, and processes to ensure compliance with GMP and other regulatory requirements.

Key Responsibilities:

• Develop, implement, and oversee validation strategies and plans, including processes for equipment, systems, facilities, cleaning, and process validation.
• Review and approve validation documents such as protocols, reports, and risk assessments.
• Coordinate and execute validation activities in line with project schedules.
• Investigate, troubleshoot, and resolve validation issues.
• Monitor validation compliance and address any deviations.
• Monitor Revalidation Program and Periodic Review.
• Provide training and support to staff regarding validation activities and protocols.
• Represent the validation department in internal and external audits.
• Stay abreast of changes in regulations and best practices related to validation.
• Development and review of SOPs

Qualifications:

• Bachelor's degree in Engineering, Science, or a related field. Advanced degree preferred.
• Minimum of 7 years of experience in validation within the pharmaceutical or biopharmaceutical industry, with at least 3 years in a leadership role.
• Thorough understanding of GMP and other relevant regulations. (FDA 21 CFR Parts 210, 211, 820, Part 11, guidelines GAMP 4 & 5, and ISO Standards)
• Strong knowledge of regulatory requirements for new drug products and the submission process.
• Knowledge of the Technology Transfer Process Life Cycle.
• Strong knowledge of validation principles and practices, including process validation, cleaning validation, computer system validation, and test method qualification.
• Excellent leadership, communication, and problem-solving skills.
• Ability to manage multiple projects and meet deadlines.
• Green Belt Six Sigma certification preferred

What we offer:

Competitive salary (DOE (Design of Experiments).)

Health, dental, and vision benefits.

Professional training and development opportunities.

Opportunities to participate in the company stock options program

Working conditions:

Physical Requirements

OFFICE POSITION - While performing the duties of this job the employee is required to:

• Stand, sit; talk, hear, and use hands and fingers to operate a computer and telephone keyboard reach, stoop kneel to install computer equipment.
• Specific vision abilities required by this job include close vision requirements due to computer work.
• Light to moderate lifting is required.
• Moderate noise (i.e., business office with computers, phones, printers, traffic light).
• Ability to sit at a computer terminal for an extended period. Sedentary work Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally, and all other sedentary criteria are met.

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