Packaging Supeprvisor

Biosimilar Sciences PR LLC

3d•Onsite

About The Position

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 for early development, pre-clinical, clinical, and commercial start. We behave more like a cGMP incubator space with all regulatory, systems capabilities, and resources to enable CMC data to support regulatory applications. Manufacturing and development spaces are designed to be autonomous while being interconnected to systems required to support clinical and commercial requirements. 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’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: As a Packaging Supervisor at OcyonBio, you will provide direct oversight of packaging operations within a cGMP-regulated biopharmaceutical manufacturing environment. You will play a critical role in the installation, qualification, start-up, and routine operation of a fully automated packaging line while fostering a culture of compliance, safety, and continuous improvement. We are seeking a technically strong, highly motivated packaging professional who thrives in a startup setting and is comfortable balancing strategic oversight with hands-on execution.

Requirements

Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline OR equivalent combination of education and experience.
Minimum of 5 years of experience in biopharmaceutical or pharmaceutical packaging operations.
Demonstrated experience working with automated packaging lines, including hands-on troubleshooting and operational support.
Direct experience supporting equipment installation, commissioning, and qualification activities (IQ/OQ/PQ).

Nice To Haves

Prior supervisory or team-lead experience within a cGMP manufacturing environment.
Strong working knowledge of FDA regulations, cGMPs, and global regulatory expectations related to packaging operations.
Experience in startup or greenfield manufacturing environments.
Proven ability to lead through ambiguity, prioritize effectively, and execute in fast-paced settings.
Excellent documentation, communication, and cross-functional collaboration skills.
Lean manufacturing or continuous improvement experience is a plus.

Responsibilities

Supervise day-to-day packaging operations, ensuring adherence to cGMPs, SOPs, batch records, and regulatory requirements.
Lead and support the installation, commissioning, qualification (IQ/OQ/PQ), and validation activities for a fully automated packaging line.
Provide hands-on technical leadership during equipment start-up, changeovers, routine operations, and troubleshooting of automated packaging systems.
Execute and review packaging batch documentation, deviation reports, change controls, and CAPAs in accordance with quality systems.
Collaborate cross-functionally with Engineering, Quality, Validation, and Supply Chain to support operational readiness and continuous improvement initiatives.
Train, coach, and develop packaging operators, fostering accountability, technical proficiency, and a strong safety culture.
Drive operational excellence through the identification and implementation of process improvements, efficiency gains, and risk mitigation strategies.
Support regulatory inspections, internal audits, and readiness activities related to packaging operations.
Operate effectively in a startup environment, demonstrating flexibility, initiative, and a “roll-up-your-sleeves” attitude to meet evolving business needs.