Manufacturing Associate – Filling (Levels I, II, III & Senior)

Manufacturing Associate – Filling (Levels I, II, III & Senior) Location: Aguadilla, PR Company: Ocyon. Bio About Ocyon. Bio Ocyon. Bio is a growing biopharmaceutical startup focused on building robust, compliant, and scalable GMP manufacturing capabilities. As an early-stage organization, we value technical rigor, accountability, and a hands-on culture where employees actively contribute to building systems, teams, and processes from the ground up.

What you will do

The Manufacturing Associate – Filling will play an essential role in supporting the start-up and ongoing operation of Ocyon. Bio's aseptic manufacturing capabilities. This individual will be responsible for executing manufacturing activities associated with the preparation, setup, operation, and cleaning of aseptic filling equipment used in the production of sterile pharmaceutical products, including prefilled syringes and vials.

This position is open to candidates at the Manufacturing Associate I, Manufacturing Associate II, Manufacturing Associate III, and Senior Manufacturing Associate levels. The appropriate level will be determined based on the candidate's educational background, relevant industry experience, technical knowledge, and demonstrated competencies.

Responsibilities

and level of independence will be aligned with the assigned position. The role requires strong attention to detail, adherence to cGMP requirements, and a commitment to aseptic practices and contamination control. The ideal candidate is a hands - on, motivated individual who can work effectively in classified cleanroom environments while contributing to the establishment of manufacturing processes and operational readiness in a startup organization.

Key responsibilities include

• Execute routine manufacturing operations associated with aseptic filling of sterile pharmaceutical products into prefilled syringes and vials in accordance with approved SOPs, batch records, and cGMP requirements.
• Perform equipment setup, assembly, disassembly, cleaning, and changeover activities for aseptic filling lines and associated manufacturing equipment.
• Support the preparation, staging, verification, and transfer of materials, components, and equipment required for aseptic filling operations.
• Operate and monitor automated and semi-automated filling equipment, following established procedures and operating parameters.
• Perform routine in-process controls, including fill volume or weight verification, component inspection, and other manufacturing checks as required by approved procedures.
• Execute approved aseptic interventions and equipment adjustments while maintaining proper aseptic practices and contamination control.
• Follow established cleanroom gowning procedures, personnel and material flows, aseptic behaviors, and contamination control requirements.
• Perform equipment and manufacturing area cleaning and disinfection activities in accordance with approved procedures.
• Accurately complete manufacturing batch records, equipment logbooks, cleaning records, and other required GMP documentation in accordance with Good Documentation Practices (GDP).
• Support equipment commissioning, qualification, and manufacturing readiness activities, including execution of approved protocols and operational testing.
• Participate in aseptic process simulations (media fills), process qualification activities, and manufacturing training exercises as required.
• Support environmental monitoring activities during manufacturing operations in coordination with Quality Control and other designated personnel.
• Identify and promptly report equipment malfunctions, process abnormalities, documentation discrepancies, or potential quality concerns to the Manufacturing Supervisor.
• Collaborate with Manufacturing, Quality, Engineering, and Facilities personnel to support production schedules, equipment readiness, and continuous improvement initiatives.
• Support equipment troubleshooting, training and mentoring of less experienced associates, and operational improvement activities as appropriate for the assigned position level.
• Participate in required training and qualification programs related to cGMP, aseptic processing, contamination control, equipment operation, and manufacturing procedures.
• Demonstrate flexibility and a willingness to support additional manufacturing activities as operational needs evolve within a startup environment.
• Other duties and responsibilities may be assigned as needed. What we want from you We are looking for motivated, detail-oriented, and dependable individuals with a strong interest in pharmaceutical manufacturing and aseptic processing. Candidates with varying levels of education and experience are encouraged to apply, as the position may be filled at the Manufacturing Associate I, II, III, or Senior level. The ideal candidate demonstrates discipline in following established procedures, a commitment to product quality and patient safety, and a willingness to develop technical skills in a highly regulated manufacturing environment.

Basic Qualifications

• High school diploma or equivalent required; an associate degree, bachelor's degree, or technical education in biotechnology, pharmaceutical manufacturing, engineering technology, or a related field is preferred.
• Previous experience in pharmaceutical manufacturing, biotechnology, medical device manufacturing, or another regulated production environment is preferred.
• Entry-level candidates with relevant technical education or training may be considered for Manufacturing Associate I positions.
• Placement at the Manufacturing Associate II, III, or Senior level will depend on relevant industry experience, demonstrated technical competencies, and the ability to perform manufacturing activities with increasing levels of independence and responsibility.
• Ability to follow written manufacturing procedures, equipment operating instructions, and established safety requirements.
• Basic understanding of manufacturing processes, equipment operation, and quality requirements.
• Strong attention to detail and ability to accurately complete manufacturing records and other required documentation.
• Ability to work independently and collaboratively in a team-oriented manufacturing environment.
• Ability and willingness to perform activities within classified cleanroom environments, including wearing required gowning and personal protective equipment (PPE).
• Ability to perform physical activities associated with manufacturing operations, including prolonged standing, walking, and handling of manufacturing materials and equipment.
• Flexibility to work different shifts, weekends, or extended hours based on manufacturing and operational requirements.

Preferred Qualifications

• Previous hands-on experience in pharmaceutical GMP manufacturing, particularly aseptic filling operations involving prefilled syringes, vials, or other sterile injectable products, is highly preferred.
• Experience operating automated or semi-automated pharmaceutical manufacturing equipment, including filling, stoppering, and associated product handling systems.
• Familiarity with aseptic processing techniques, cleanroom classifications, gowning procedures, and contamination control practices.
• Experience working with Restricted Access Barrier Systems (RABS), isolators, or other aseptic processing technologies.
• Knowledge of cGMP regulations, Good Documentation Practices (GDP), and standard operating procedures.
• Experience performing equipment setup, line clearance, cleaning, disinfection, and manufacturing changeover activities.
• Familiarity with in-process controls, batch record execution, and routine manufacturing documentation.
• Previous participation in equipment qualification activities, aseptic process simulations (media fills), or process validation exercises.
• Experience supporting equipment troubleshooting, training, mentoring, or technical leadership of manufacturing personnel is preferred for Level III and Senior positions.
• Strong problem-solving skills, attention to detail, and a commitment to maintaining high quality and safety standards.
• Ability to learn new manufacturing processes and equipment quickly and adapt to changing operational priorities. Why Ocyon. Bio At Ocyon. Bio, you will have the opportunity to contribute directly to the establishment and operation of modern aseptic pharmaceutical manufacturing capabilities. As part of a growing organization, you will gain valuable hands-on experience in sterile drug product manufacturing, advanced filling technologies, equipment qualification, and GMP operations while working alongside experienced industry professionals.