Sterile/ Aseptic Manufacturing Automation filing Operator/Technician

Xseer Pharma; Los Angeles (CA); On-site; USD 60,000 - 90,000; Full time

Job summary

Xseer Pharmaceuticals in Los Angeles is seeking a Sterile/ Aseptic Manufacturing Automation filing Operator/Technician to oversee and execute sterile product manufacturing at the 503B facility. You will follow 21 CFR parts, USP, cGMP, and SOPs while ensuring ISO cleanroom standards.

The role emphasizes adherence to safety, quality systems, and teamwork with the production staff to meet daily targets and maintain equipment performance.

Qualifications

• High School Diploma or equivalent required.
• Previous aseptic manufacturing experience required; 503B experience preferred.
• Experience with operation of equipment and/or tools required.

Responsibilities

• Performs sterile manufacturing in a cGMP cleanroom (ISO 5/ISO 7).
• Manufactures sterile products per master batch records and SOPs.
• Maintains ISO classified cleanroom through cleaning and disinfection.
• Adheres to GMP, QA guidelines, and safety procedures.
• Assists in maintenance and troubleshooting of filling equipment.

Skills

Computer skills

Mechanical skills

Aseptic manufacturing

Education

High School Diploma

Tools

Manufacturing equipment operation

Job description

Sterile/ Aseptic Manufacturing Automation filing Operator/Technician

Position Summary:

The Sterile Manufacturing Automation filing Operator is responsible for overseeing, and executing where needed, all processes related to the manufacture of sterile products at Xseer’s 503B facility. Manufacturing personnel must adhere to 21 CFR parts 210/211 and USP / regulations, current Good Manufacturing Practices (cGMP), and department’s Standard Operating Procedures (SOPs).

Duties And Responsibilities:

• Performs sterile manufacturing in a cGMP cleanroom environment (ISO 5, ISO 7).
• Manufactures sterile products accurately and in compliance with master batch records while adhering to department specific SOPs and SSOP’s (standard operating procedures and sanitation standard operating procedures).
• Utilizes and coaches’ team on appropriate aseptic technique when performing tasks within the cleanroom.
• Operates all fill-finish and ancillary manufacturing equipment in order to deliver quality medication.
• Maintains an ISO classified environment through rigorous cleaning and disinfecting of the cleanroom in accordance with approved procedures.
• Adheres to, and completes, standard work documents, ensuring designated shift personnel understand and achieve daily target goals.
• Assists with sterilization of components used in the manufacturing process.

Key Accountabilities:

• Safety:
• Adheres to all plant safety rules.
• Reports all near misses and accidents to the manufacturing lead and/or Manager.
• Serves an active role the plant safety programs, by participating in monthly safety inspections and reporting any potential safety hazards to the Manufacturing Management.
• Quality:
• Adheres to all Quality Assurance System guidelines and procedures.
• Follows SOP’s when making processing adjustments, to ensure the manufacturing of high-quality liquid-based products.
• Responsible for compliance with the GMP's and all internal Policy and Procedures.
• Identifies all critical control points understanding their functions as it relates to the filling process.
• Maintenance:
• When maintenance is occurring in your work area, it is the expectation to assist the Maintenance Technicians in any capacity needed to expedite the repair process.
• When equipment is in a state of disrepair these items must be reported ASAP to avoid breakdowns.
• Maintains a clean and organized work area.
• Assists all areas of the plant with general housekeeping.
• Cooperates with other members and the management team in the housekeeping endeavors
• Communications:
• As a member of the Production team, ensure effective communication and teamwork with the other operators occurs.
• Maintains effective communication with members of the support group.
• Teamwork and Training:
• Promotes and contributes to the development of a strong team.
• Works well among co-workers as a team.
• Assist in coaching and training employees as requested by the operation management team.
• Personal Development:
• Continuously improve your knowledge of the Aseptic Filling process.
• Become familiar with filing machine maintenance and troubleshooting.

Preferred Qualifications:

• Working knowledge of computer and math.
• Mechanical and troubleshooting skills.
• Aseptic manufacturing and ISO5 PPE.

Knowledge and Skills:

• The candidate must be able to work effectively in a team-based environment, set priorities to meet deadlines, handle multiple tasks, and make decisions under pressure.
• Must be able to stand (12) hours for long periods of time
• Must be able to keep a good attendance record.
• Must have accurate and detailed record keeping and legible handwriting.
• Must be able to troubleshoot and resolve moderate to complex issues.
• Understands all policies and procedures.
• Must follow all GMP's and Safety Procedures established by Management.
• Ability to access a situation and make quick and accurate decisions that will aid in production.

Experience and Minimum Qualifications:

• High School Diploma or equivalent required.
• Previous aseptic manufacturing experience required. 503B experience preferred.
• Experience with operation of equipment and/or tools required.

Additional Considerations:

• Location: This position will be at the Xseer Pharmaceuticals outsourcing facility on Westwood Blvd., Los Angeles.