Process Engineer 1

Job Description

Job Posting Title:

Process Engineer I

Job Description

Company:

OcyonBio is a partnership development and manufacturing organization focused on advancing gene and cell therapies.

OcyonBio provides dedicated autonomous manufacturing capacity with interconnected infrastructure and systems to support phased-appropriate development from early development through pre-clinical, clinical, and commercial stages. We operate as a cGMP incubator environment with full regulatory systems capabilities and resources to generate CMC data supporting global regulatory applications. Our manufacturing and development spaces are designed to function autonomously while remaining fully integrated with the systems required to support clinical and commercial operations.

We are committed to fostering a workplace free of explicit and implicit discrimination and harassment, where every individual feels safe, heard, and valued. The character of our employees is as important as their talent, and we’re proud of the team and environment we’re assembling as we grow.

Place of Performance:

CII George Sanders, Aguadilla Pueblo, Aguadilla, P.R. 00603.

Job Overview

The Process Engineer I supports the design, analysis, and optimization of manufacturing processes within OcyonBio’s cGMP-regulated environment. This role collaborates with cross-functional teams to improve efficiency, quality, compliance, and operational performance across formulation, filling, packaging, utilities, and related systems.

The Process Engineer I plays a key role in troubleshooting process deviations, supporting technology transfer, and contributing to continuous improvement initiatives aligned with regulatory and business objectives.

Responsibilities

• Analyze manufacturing and operational processes to identify inefficiencies and recommend improvements.

• Develop and maintain process workflows, SOPs, technical specifications, and supporting documentation.

• Collaborate with Engineering, Quality Assurance, Production, and Validation teams to implement process changes and verify effectiveness.

• Conduct root cause analysis for process deviations and support corrective and preventive action (CAPA) implementation.

• Collect and analyze process data to measure performance and support continuous improvement initiatives.

• Assist in equipment design review, installation, commissioning, and qualification activities (IQ/OQ/PQ).

• Support technology transfer and scale-up activities for new products or processes.

• Ensure compliance with cGMP, safety, quality, and regulatory standards during process development and optimization.

QualificationsEducation & Experience

• Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Industrial Engineering, or related field required.

• Internship, co-op, or entry-level experience in process engineering or manufacturing environments preferred.

• Experience in pharmaceutical, biotechnology, or regulated manufacturing environments is a plus.Knowledge, Skills & Abilities

• Basic understanding of process engineering principles and manufacturing operations.

• Proficiency in data analysis and process modeling tools.

• Strong analytical and problem-solving skills.

• Ability to interpret technical drawings, P&IDs, and process documentation.

• Effective communication skills to collaborate with multidisciplinary teams.

• Familiarity with Lean Manufacturing, Six Sigma, or continuous improvement methodologies preferred.

• Knowledge of cGMP and regulatory requirements preferred.

Preferred:

• Engineer in Training (EIT) or Fundamentals of Engineering (FE) certification.

• Experience with CAD, MATLAB, or other engineering software tools.

Working Conditions

• Combination of office-based engineering work and presence in manufacturing and cleanroom environments.

• Prolonged periods of sitting and computer use for data analysis and documentation.

• Required use of appropriate PPE when entering manufacturing or laboratory areas.

• Ability to stand, walk, and perform equipment assessments as needed.

• Ability to lift up to 25 pounds occasionally.

What We Offer

• Competitive salary (DOE.)

• Health, dental, and vision benefits

• Professional training and development opportunities

• Opportunities to participate in the company stock options program

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.

If you are looking to contribute to a growing organization advancing next-generation therapies while building your career in a dynamic and collaborative environment, OcyonBio offers the opportunity to make a meaningful impact. Join us as we continue shaping the future of healthcare.

To learn more about us, please visit our website:

Full-time