Manufacturing Operator

Job Description

Job Description

Job Description: Manufacturing Operator

OcyonBio PR Inc. is seeking a motivated and adaptable Manufacturing Operator to support a wide range of manufacturing activities within our GMP facility. This role will provide hands-on support across formulation, aseptic filling, visual inspection, packaging, and sanitation operations, depending on production needs. The operator will be responsible for maintaining compliance with cGMP standards, performing work in classified cleanroom environments (ISO 7, ISO 8, CNC), and ensuring accurate documentation of activities.

As part of a startup organization, the General Manufacturing Operator will also contribute to the development of SOPs, batch records, and training documents, helping to establish compliant and scalable processes for OcyonBio’s long-term growth.

Key Responsibilities

• Execute a variety of manufacturing tasks including solution preparation, aseptic filling support, visual inspection, packaging, and cleanroom sanitation.
• Follow and help create SOPs, work instructions, and batch records to ensure regulatory compliance and operational consistency.
• Operate and maintain manufacturing equipment, ensuring proper setup, cleaning, and routine checks.
• Accurately document all activities in GMP-compliant records.
• Support environmental controls by maintaining a clean and organized work area in CNC, ISO 8, and ISO 7 spaces.
• Assist with tech transfer activities and support scale-up of new processes.
• Participate in training and cross-training to gain proficiency across multiple functional areas.
• Report any deviations, equipment malfunctions, or safety concerns promptly.

Qualifications

• High school diploma or equivalent required; Associate’s or Bachelor’s degree in Life Sciences, Biotechnology, Engineering, or related field preferred.
• Strong attention to detail and ability to follow instructions and procedures precisely.
• Knowledge of GMP principles and cleanroom operations preferred.
• Comfortable working in controlled environments requiring gowning and PPE.
• Ability to adapt to a dynamic startup environment and manage shifting priorities.

Preferred Experience

• Prior experience in pharmaceutical, biopharmaceutical, or regulated manufacturing.
• Exposure to one or more areas such as formulation, filling, inspection, packaging, or sanitation.
• Familiarity with documentation practices, including SOPs, batch records, or training guides.
• Experience in technical writing or document generation in a regulated environment is highly desirable.

What we offer

• Competitive salary (DOE)
• Health, dental, and vision benefits.
• Professional training and development opportunities.
• Opportunities to participate in the company stock options program.

Working Conditions / Physical Requirements

This position requires working in controlled environments, including CNC, ISO 8, and ISO 7 cleanrooms, with the use of appropriate gowning and personal protective equipment (PPE). Operators must be able to stand, walk, bend, and reach for extended periods while performing manufacturing activities such as solution preparation, aseptic support, inspection, packaging, and sanitation. The role also involves handling manufacturing equipment, lifting items up to 25 lbs, and adhering to strict cGMP, safety, and contamination-control practices at all times

We Are An Equal Opportunity Employer

Ocyonbio provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity, or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

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To learn more about us, please visit our website: https://ocyonbio.com