Computer System Validation Specialist (Biolog

Job Title: Computer System Validation Specialist (Biologics Drug Product)

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:

OcyonBio is currently seeking a dynamic and experienced Computer System Validation Specialist to join our pharmaceutical company. We are seeking a highly skilled and experienced Computer System Validation Specialist with expertise in Biologics Drug Product manufacturing. As a key member of our team, you will play a critical role in ensuring the compliance and validation of computer systems used in the production and quality control of biologics drug products.

Key Responsibilities:

1. Validation Planning: Develop and execute validation strategies and protocols for computer systems used in biologics manufacturing, ensuring alignment with industry standards and regulatory requirements.

2. Risk Assessment: Conduct risk assessments for computer systems and develop mitigation plans to address potential issues.

3. Validation Documentation: Create, review, and maintain validation documentation, including Validation Plans, User Requirements Specifications, Functional Specifications, and Test Protocols.

4. Execution and Testing: Perform validation testing, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), and ensure systems meet predefined acceptance criteria.

5. Change Control: Manage change control processes for computer systems, ensuring compliance with regulatory requirements.

6. Validation Reporting: Prepare validation reports and summaries for regulatory submissions and audits.

7. Collaboration: Work closely with cross-functional teams, including Quality Assurance, Manufacturing, and IT, to ensure validation activities are carried out effectively.

Qualifications:

• Bachelor's degree in a relevant field (e.g., Computer Science, Engineering, or Life Sciences).
• Minimum 5 years of experience in Computer System Validation within the biologics drug product manufacturing industry.

• Strong knowledge of regulatory requirements, including FDA cGMP, 21 CFR Part 11, and EU GMP Annex 11.
• Proficiency in validation tools and methodologies.
• Excellent communication and documentation skill.
• Ability to work independently and collaboratively in a fast-paced environment.

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

• 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 restate,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