Curia Jobs

Lyophilization Technician

Summary

The lyophilization technician is responsible for the site’s clinical and commercial function, including the operation of lyophilization equipment and participation in production activities relating to lyophilization. The lyophilization department ensures standard operating procedures (SOPs) and current good manufacturing practices (cGMPs). The technician completes all associated master batch record (MBR) documentation and assists in developing and reviewing SOPs relating to the department, completing all associated quality reporting documentation. The technician ensures the lyophilizers are sterilized and leak-tested before manufacturing. Operate the lyophilizers according to specifications, monitor cycles, review data to confirm requirements, and complete all associated documentation. Cleaning operations occur in a cleanroom environment and by strict standards of sterility and regulatory agencies.

Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients’ lives with the pharmaceuticals we develop and manufacture.

Essential Duties and Responsibilities:

• Ensures lyophilizers are cleaned, sterilized, and leak tested before manufacturing. The technician operates lyophilizers according to the product specifications, including temperature, pressure, time, etc. Monitors lyophilization cycles and reviews data to ensure requirements of product SOPs requirements.

• Communicate with production and engineering staff about the status of lyophilizer operations. Assists other shifts as needed. Understand and follow cGMP.

• Understand and follow safety practices—other duties specified by the Lyophilization Supervisor. Comprehend and follow SOPs, cGMPs, and good aseptic techniques to produce sterile quality products.

• Aseptic gowning for various classifications of cleanroom areas. Documentation and review of associated paperwork for accuracy and clarity. Working with peers to help train each other as directed by Production Management—other miscellaneous duties as required by supervisor.

Supervisory Responsibilities:

This job has no supervisory responsibilities

Education and/or Experience:

The minimum education requirement is having a High school diploma or general education degree (GED) combination of education and experience with a minimum of less than two (2) years of experience in a manufacturing/production environment.

Language Skills:

Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Understand, Interpret, and apply technical writing and education.

Mathematical Skills:

Have the ability to apply math and physics science concepts.

Reasoning Ability:

Have the ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form.

Computer Skills:

To perform this job successfully, an individual should know about manufacturing, spreadsheets, and Word Processing software—working knowledge of MS Office.

Other Skills and Abilities;

• Follow detailed instructions, utilize good written/communication skills, and have some basic computer skills.

• Can perform documentation duties and projects that relate solely to the filling department.

Other Qualifications:

Must pass a background check

Must pass a drug screen

Physical Demands:

While performing the duties of this job, the employee is regularly required to talk or hear. Employees must frequently sit and use their hands to finger, handle, or feel. The employee is occasionally required to stand; walk; reach with hands and arms; climb or balance, stoop, kneel, crouch, or crawl. The employee must regularly lift and /or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, and depth perception.

Work Environment:

While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts; high, precarious places; fumes or airborne particles; toxic or caustic chemicals; risk of electrical shock; explosives; risk of radiation, and vibration. The noise level in the work environment is usually moderate.

All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. CURIA is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Curia is an E-Verify employer.

Note

This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employees will be required to follow any other job-related instructions and perform any other job-related duties requested by anyone authorized to give instructions or assignments. All duties and responsibilities are essential functions and requirements and are subject to possible modification to accommodate individuals with disabilities reasonably. To perform this job successfully, the incumbents will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities. This document does not create an employment contract, implied or otherwise, other than an “at-will” relationship.

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