Aseptic Filling Technician (I–Senior) – GMP Startup

Biosimilar Sciences PR LLC; Aguadilla (PR); Presencial; USD 42.000 - 64.000; Jornada completa

Descripción de la vacante

OcyonBio seeks a Manufacturing Associate – Filling (Levels I–Senior) in Aguadilla, PR. You will perform aseptic filling of sterile products into syringes and vials, set up lines, and ensure GMP-compliant documentation in a fast-paced startup environment.

Ideal candidates have attention to detail, strong teamwork, and adaptability, with readiness to follow procedures and support qualification activities. Training and growth opportunities available.

Formación

• High school diploma or equivalent required; degree/technical education in biotech, pharma, engineering is preferred.
• Experience in pharmaceutical manufacturing or regulated production is preferred.
• Entry-level candidates may be considered for Manufacturing Associate I.
• Promotion to II/III/Senior depends on experience and competencies.
• Ability to follow written procedures and safety requirements.
• Careful documentation and record-keeping are essential.
• Willingness to work in a cleanroom with gowning and PPE.
• Flexibility for different shifts, weekends, or extended hours.

Responsabilidades

• Execute aseptic filling operations for sterile products into syringes and vials per SOPs and GDP.
• Set up, assemble, disassemble, clean and changeover filling lines and equipment.
• Assist material transfer and equipment readiness for aseptic filling operations.
• Operate automated and semi-automated filling equipment per procedures.
• Perform in-process controls such as fill volume/weight verification and component inspection.
• Maintain aseptic practices and contamination control.
• Follow cleanroom gowning procedures and material flows.
• Document batch records, equipment logs, and GDP-compliant records.
• Support equipment qualification, commissioning, and manufacturing readiness activities.
• Participate in media fills and process qualification activities.
• Coordinate with Quality Control and other designated personnel.
• Report equipment malfunctions and process deviations promptly.
• Collaborate with manufacturing, quality, engineering and facilities to meet schedules.
• Help train and mentor less experienced associates.
• Engage in training programs related to cGMP and aseptic processing.
• Support additional duties as startup needs evolve.

Conocimientos

Attention to detail

Teamwork

Procedural compliance

Safety awareness

Adaptability

Educación

High school diploma or equivalent

Related degree/technical education preferred

Descripción del empleo

OcyonBio seeks a Manufacturing Associate – Filling (Levels I–Senior) in Aguadilla, PR. You will perform aseptic filling of sterile products into syringes and vials, set up lines, and ensure GMP-compliant documentation in a fast-paced startup environment.

Ideal candidates have attention to detail, strong teamwork, and adaptability, with readiness to follow procedures and support qualification activities. Training and growth opportunities available.