Job Description

Position Summary

The Aseptic Manufacturing Operator is a key contributor to the production of high-quality sterile products while maintaining the highest standards of compliance and excellence. This role supports the integrity and safety of manufacturing processes, ensuring that every product meets stringent quality standards.

Operating in cleanroom environments (ISO 5, ISO 7, ISO 8), this position involves meticulous manufacturing of sterile products, adhering to master batch records and Standard Operating Procedures (SOPs). Using aseptic techniques and specialized equipment, the operator performs critical tasks such as autoclaving, bubble point testing, and material preparation, ensuring compliance with Current Good Manufacturing Practices (cGMP).

This role offers opportunities for continuous improvement initiatives, mentoring new hires, and directly contributing to the production of safe and effective medications.

Essential Functions

• Execute sterile product manufacturing processes in cGMP cleanroom environments (ISO 5, ISO 7, ISO 8).
• Follow master batch records and department-specific SOPs to ensure compliance.
• Operate fill-finish and ancillary manufacturing equipment.
• Maintain cleanroom sterility through rigorous cleaning and disinfecting practices.
• Perform material sterilization, autoclaving, and bubble point testing.
• Accurately complete calculations and thorough documentation.
• Prepare the work area and materials for manufacturing.
• Support inventory accounting, Lean manufacturing tasks (6S, Gemba, Kaizen), and other ancillary duties.
• Observe and coach new hires on aseptic operations.
• Provide overtime support to maintain inventory levels, as needed.
• Assist with special projects and other tasks as assigned.

Physical Requirements:

• Ability to work in a stationary position for extended periods and perform tasks requiring dexterity.
• Fully gown in aseptic garb and work in confined, controlled environments for up to 4–6 hours.
• Handle hazardous substances and strong odors (e.g., peracetic acid).
• Stand, walk, and lift up to 50 lbs as required.

Knowledge & Skills

• Ability to follow technical and written documents (SOPs) and detailed oral instructions.
• Strong attention to detail and self-motivation.
• Problem-solving skills with a collaborative mindset.
• Ability to perform basic math operations (addition, subtraction, multiplication, division).
• Achieve “Gown Qualified” status within two attempts for cleanroom entry.

Key Competencies

• Customer Focus: Build strong customer relationships and deliver tailored solutions.
• Optimizes Work Processes: Focus on efficiency and continuous improvement.
• Collaboration: Foster teamwork and partnerships to achieve goals.
• Resourcefulness: Deploy resources effectively to meet objectives.
• Complexity Management: Understand and solve high-quality, complex problems.
• Accountability: Take responsibility for meeting commitments.
• Adaptability: Adjust actions and demeanor to evolving demands.
• Effective Communication: Deliver clear, audience-focused communication.

Values

• People: Prioritize the needs of employees, clients, and the community to foster support and growth.
• Quality: Commit to excellence in every product.
• Service: Approach every interaction with a service mindset.
• Innovation: Embrace new methodologies and technology for cutting-edge solutions.

Education & Experience

• Required: High School Diploma or equivalent.
• Preferred:
• 1-5+ years of manufacturing experience.
• Experience in cGMP or Lean manufacturing.
• Familiarity with equipment and tool operations.

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