Compunnel
Job Summary:
We are seeking an experienced Production Technician with prior **isolator and pharmaceutical manufacturing experience** to join our Manufacturing department. This mid-level role involves executing aseptic filling operations in a strictly controlled **GMP environment**, supporting pharmaceutical production processes while ensuring quality and regulatory compliance. The technician will perform cleanroom operations, equipment setup, sanitization, and aseptic filling, while demonstrating increasing technical competency and leadership within the team.
Key Responsibilities: Obtain certification for GMP cleanroom entry and perform sanitization, stock replenishment, and equipment setup to support aseptic filling operations. Execute aseptic fill processes in accordance with batch records, Standard Operating Procedures (SOPs), and GMP requirements. Verify calibration of related equipment and proper sanitization of supplies used in production. Perform job duties in aseptic and cleanroom areas, including **Component Preparation, Filling, and Capping**. Operate and maintain equipment within the Fill suite. Work independently with minimal supervision while maintaining adherence to safety and quality standards. Train new team members on aseptic filling procedures and GMP practices. Coordinate daily tasks in line with the production schedule to ensure timely completion of manufacturing goals. Provide leadership on the production floor in the absence of a supervisor or senior technician. Safely transport and dispose of hazardous chemicals in accordance with company policies. Adhere to all personal hygiene and health requirements—individuals with infectious diseases or open lesions are not permitted in manufacturing areas. Perform additional duties as assigned by the supervisor. Required Skills:
Proven experience in **aseptic filling operations** within a **cGMP pharmaceutical manufacturing** environment. Strong understanding of **GMP compliance regulations** and aseptic techniques. Hands-on experience with equipment cleaning, preparation, and assembly; stopper preparation, capping, and packaging experience preferred. Ability to read and comprehend detailed procedural instructions and documentation. Strong arithmetic skills to perform accurate calculations in production documentation. Effective communication skills (verbal and written) in English. Ability to provide training and floor-level guidance to peers. Computer literacy, particularly in **Microsoft Office (Word, Excel)**, is a plus.
Education:
High school diploma or equivalent required.
College coursework or technical training preferred.
Experience:
Minimum **3–5 years of relevant aseptic filling experience** in a cGMP pharmaceutical environment.
Prior experience with **isolators** and **SIP100 exposure** required.
We are seeking an experienced Production Technician with prior **isolator and pharmaceutical manufacturing experience** to join our Manufacturing department. This mid-level role involves executing aseptic filling operations in a strictly controlled **GMP environment**, supporting pharmaceutical production processes while ensuring quality and regulatory compliance. The technician will perform cleanroom operations, equipment setup, sanitization, and aseptic filling, while demonstrating increasing technical competency and leadership within the team.
Key Responsibilities: Obtain certification for GMP cleanroom entry and perform sanitization, stock replenishment, and equipment setup to support aseptic filling operations. Execute aseptic fill processes in accordance with batch records, Standard Operating Procedures (SOPs), and GMP requirements. Verify calibration of related equipment and proper sanitization of supplies used in production. Perform job duties in aseptic and cleanroom areas, including **Component Preparation, Filling, and Capping**. Operate and maintain equipment within the Fill suite. Work independently with minimal supervision while maintaining adherence to safety and quality standards. Train new team members on aseptic filling procedures and GMP practices. Coordinate daily tasks in line with the production schedule to ensure timely completion of manufacturing goals. Provide leadership on the production floor in the absence of a supervisor or senior technician. Safely transport and dispose of hazardous chemicals in accordance with company policies. Adhere to all personal hygiene and health requirements—individuals with infectious diseases or open lesions are not permitted in manufacturing areas. Perform additional duties as assigned by the supervisor. Required Skills:
Proven experience in **aseptic filling operations** within a **cGMP pharmaceutical manufacturing** environment. Strong understanding of **GMP compliance regulations** and aseptic techniques. Hands-on experience with equipment cleaning, preparation, and assembly; stopper preparation, capping, and packaging experience preferred. Ability to read and comprehend detailed procedural instructions and documentation. Strong arithmetic skills to perform accurate calculations in production documentation. Effective communication skills (verbal and written) in English. Ability to provide training and floor-level guidance to peers. Computer literacy, particularly in **Microsoft Office (Word, Excel)**, is a plus.
Education:
High school diploma or equivalent required.
College coursework or technical training preferred.
Experience:
Minimum **3–5 years of relevant aseptic filling experience** in a cGMP pharmaceutical environment.
Prior experience with **isolators** and **SIP100 exposure** required.