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

Biosimilar Sciences PR LLC • Aguadilla, PR, PR, PR

2d • Onsite

About The Position

OcyonBio is hiring a Manufacturing Associate – Filling at the I, II, III, or Senior level to support the start-up and ongoing operation of its aseptic manufacturing capabilities in Aguadilla, Puerto Rico. The role involves preparing, setting up, operating, and cleaning aseptic filling equipment used to manufacture sterile pharmaceutical products, including prefilled syringes and vials. The level and scope of independence will be based on the candidate’s education, relevant industry experience, technical knowledge, and demonstrated competencies.

The position requires careful adherence to cGMP requirements, approved procedures, aseptic practices, and contamination-control requirements. The associate will work in classified cleanroom environments and help establish manufacturing processes and operational readiness in a startup organization. The role collaborates with Manufacturing, Quality, Engineering, and Facilities personnel and may include equipment troubleshooting, mentoring less experienced associates, and other manufacturing activities as operational needs evolve.

Candidates with varying levels of education and experience are encouraged to apply. A high school diploma or equivalent is required; postsecondary or technical education and regulated-manufacturing experience are preferred. Entry-level candidates with relevant technical education or training may be considered for Level I. The company offers hands-on experience with sterile drug product manufacturing, filling technologies, equipment qualification, and GMP operations alongside experienced industry professionals.

Requirements

• High school diploma or equivalent.
• 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 complete manufacturing records and other required documentation accurately.
• Ability to work independently and collaboratively in a team-oriented manufacturing environment.
• Ability and willingness to work in classified cleanroom environments while wearing required gowning and personal protective equipment.
• Ability to perform manufacturing-related physical activities, including prolonged standing and walking and handling manufacturing materials and equipment.
• Flexibility to work different shifts, weekends, or extended hours based on manufacturing and operational requirements.

Nice To Haves

• Associate degree, bachelor’s degree, or technical education in biotechnology, pharmaceutical manufacturing, engineering technology, or a related field.
• Previous experience in pharmaceutical manufacturing, biotechnology, medical device manufacturing, or another regulated production environment.
• Relevant technical education or training for consideration at the Manufacturing Associate I level.
• Relevant industry experience, demonstrated technical competencies, and ability to work with increasing independence and responsibility for consideration at the II, III, or Senior level.
• Hands-on pharmaceutical GMP manufacturing experience, particularly aseptic filling of prefilled syringes, vials, or other sterile injectable products.
• Experience operating automated or semi-automated pharmaceutical manufacturing equipment, including filling, stoppering, and product-handling systems.
• Familiarity with aseptic processing techniques, cleanroom classifications, gowning procedures, and contamination-control practices.
• Experience with Restricted Access Barrier Systems (RABS), isolators, or other aseptic processing technologies.
• Knowledge of cGMP regulations, Good Documentation Practices, and standard operating procedures.
• Experience with equipment setup, line clearance, cleaning, disinfection, and manufacturing changeovers.
• Familiarity with in-process controls, batch record execution, and routine manufacturing documentation.
• Participation in equipment qualification, aseptic process simulations (media fills), or process validation exercises.
• Equipment troubleshooting, training, mentoring, or technical leadership experience, particularly for Level III and Senior positions.
• Strong problem-solving skills and commitment to high quality and safety standards.
• Ability to learn manufacturing processes and equipment quickly and adapt to changing operational priorities.

Responsibilities

• Execute routine aseptic filling operations for sterile pharmaceutical products, including prefilled syringes and vials, in accordance with approved SOPs, batch records, and cGMP requirements.
• Set up, assemble, disassemble, clean, and change over aseptic filling lines and associated manufacturing equipment.
• Prepare, stage, verify, and transfer materials, components, and equipment needed for aseptic filling operations.
• Operate and monitor automated and semi-automated filling equipment according to established procedures and operating parameters.
• Perform routine in-process controls, including fill-volume or weight verification, component inspection, and other required manufacturing checks.
• Perform approved aseptic interventions and equipment adjustments while maintaining aseptic practices and contamination control.
• Follow cleanroom gowning procedures, personnel and material flows, aseptic behaviors, and contamination-control requirements.
• Clean and disinfect equipment and manufacturing areas according to approved procedures.
• Complete batch records, equipment logbooks, cleaning records, and other required GMP documentation accurately and in accordance with Good Documentation Practices.
• Support equipment commissioning, qualification, manufacturing readiness, approved protocols, and operational testing.
• Participate in aseptic process simulations (media fills), process qualification activities, and manufacturing training exercises as required.
• Support environmental monitoring during manufacturing operations in coordination with Quality Control and other designated personnel.
• Promptly report equipment malfunctions, process abnormalities, documentation discrepancies, and potential quality concerns to the Manufacturing Supervisor.
• Collaborate with Manufacturing, Quality, Engineering, and Facilities to support production schedules, equipment readiness, and continuous improvement.
• Support equipment troubleshooting, training and mentoring of less experienced associates, and operational improvements as appropriate to the assigned level.
• Complete required training and qualification programs related to cGMP, aseptic processing, contamination control, equipment operation, and manufacturing procedures.
• Support additional manufacturing activities as operational needs evolve and perform other duties as assigned.

Benefits

• Opportunity to contribute directly to establishing and operating modern aseptic pharmaceutical manufacturing capabilities.
• Hands-on experience in sterile drug product manufacturing, advanced filling technologies, equipment qualification, and GMP operations.
• Opportunity to work alongside experienced industry professionals.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED