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

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

Location: Aguadilla, PR

Company: OcyonBio

About OcyonBio

OcyonBio 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 OcyonBio'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 OcyonBio

At OcyonBio, 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.