Sterile Manufacturing Technician

Global Blockchain Talent; Monroe (NC); On-site; USD 35,000 - 55,000; Full time

Job summary

An established industry player is seeking a dedicated Sterile Manufacturing Technician to join their team. This role focuses on the production of sterile liquids for commercial distribution and clinical trials, requiring meticulous attention to detail and adherence to FDA CGMP standards. You will be responsible for operating manufacturing equipment, maintaining a quality-focused production mentality, and ensuring compliance with safety procedures. This position offers an opportunity to grow within a supportive environment that values ethical practices and personal development. If you have a passion for excellence in manufacturing and a strong mechanical aptitude, this is the perfect opportunity for you.

Qualifications

• 2-4 years experience in CGMP/aseptic operations.
• Ability to follow procedures and instructions.

Responsibilities

• Troubleshoot basic machine issues and coordinate maintenance support.
• Master aseptic processing steps including cleaning and sterilization.
• Accurately document activities in batch records and logbooks.

Skills

Mechanical aptitude

Familiarity with computer applications

Knowledge of the metric weight system

Strong math skills

Documentation skills

Organizational skills

Ability to lift 40-50 lbs

Manual dexterity

Basic knowledge of CGMPs

Education

High School Diploma

Associate Degree

Job description

Career Opportunities with Glenmark Pharmaceuticals Inc.

A great place to work.

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Job Title: Sterile Manufacturing Technician

The Sterile Manufacturing Technician is responsible for manufacturing sterile liquids for commercial distribution and clinical trials. Responsibilities include supporting production by handling aseptic cleaning and specializing in areas such as cleaning, formulation, aseptic filling, equipment preparation, and terminal sterilization. The role involves operating manufacturing equipment following SOPs and batch records in compliance with FDA CGMP standards. The technician will employ mechanical aptitude and aseptic techniques in controlled environments, some requiring gowning. Support in inspection and packaging areas may also be required.

Key Responsibilities:

1. Troubleshoot basic machine issues and coordinate maintenance support to meet production timelines.
2. Set up filling equipment specific to each area.
3. Master aseptic processing steps including cleaning, sterilization prep, product assembly, filtration, filling, and sterilization.
4. Maintain a detailed, quality-focused production mentality.
5. Train other operators.
6. Accurately document activities in batch records and logbooks.
7. Perform basic math calculations and weight checks.
8. Submit in-process samples to relevant departments.
9. Perform cleaning of rooms, tools, and equipment.
10. Conduct visual inspections based on outlined checks and specifications.
11. Ensure product meets specifications.
12. Maintain Aseptic Gown Certification.
13. Operate autoclaves for sterilization as needed.
14. Review SOPs and protocols thoroughly.

Additional Responsibilities:

• Operate, maintain, and set up production equipment.
• Execute batch records and produce materials with high quality standards.
• Maintain documentation and work areas per CGMP standards.
• Lift and move heavy equipment parts and containers.

Qualifications and Skills:

• Mechanical aptitude.
• Familiarity with computer applications.
• Knowledge of the metric weight system.
• Ability to follow procedures and instructions.
• Strong math, documentation, and organizational skills.
• Ability to lift 40-50 lbs.
• Manual dexterity.
• Basic knowledge of CGMPs.
• Accurate data transcription per CGMP and SOP standards.
• Willingness to work overtime and maintain good attendance.

Standards and Culture:

Operate ethically and safely, comply with procedures, build trust, and communicate openly. Foster strong, diverse teams, attract and develop talent, and support technology transfer processes. Drive production excellence while balancing personal and professional growth.

Educational and Experience Requirements:

• High School Diploma or Associate Degree preferred.
• 2-4 years experience in CGMP/aseptic operations.