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Senior Lyophilization Craftsman

Curia provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.

The lyophilization department is responsible for the clinical and commercial lyophilization function within the site. This includes operation of lyophilization equipment, and participation in production activities relating to lyophilization. The lyophilization department ensures that standard operating procedures (SOP's) and current good manufacturing practices (cGMP's) are followed at all times. The lyophilization department completes all associated master batch record (MBR) documentation and assists in the development and review of SOP’s relating to the department, completes all associated quality reporting documentation.

The lyophilization technician is part of a team responsible for the daily duties of ensuring the lyophilizers are cleaned, sterilized and leak tested prior to manufacturing of product, operates the lyophilizers according to specifications, monitors cycles and reviews data to ensure requirements have been met, and completes all associated documentation. Cleaning operations occur in a clean room environment and is governed 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 prior to manufacturing of product.

• Operates lyophilizers according to the product specifications including temperature, pressure, time, etc.

• Monitors lyophilization cycles and reviews data to ensure requirements of product SOP’s have been met.

• Assists in the development and review of SOP’s and technical reports pertaining to lyophilizer operations.

• Communicates with production and engineering staff pertaining to status of lyophilizer operations.

• Assists in the development of quality reports including, but not limited to, planned deviations and non-conforming material reports.

• Assists other departments and shifts as needed.

• Understands and follows C.G.M.P.

• Understands and follows safety practices.

• Training for newly hired technicians and current technicians as needed.

• Other duties as specified by the lyophilization supervisor

Supervisory Responsibilities:

This job has no supervisory responsibilities.

Education and/or Experience:

• Associates degree with an emphasis in applied science or equivalent education and experience.

• At least 1-2 years as a lyophilization technician, plus minimum 1-2 years in a pharmaceutical manufacturing industry or equivalent education and experience

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 instruction.

Mathematical Skills:

Ability to apply math and physic science concepts.

Reasoning Ability:

Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.

Computer Skills:

To perform this job successfully, an individual should have knowledge of manufacturing software; spreadsheet software and word processing software.

Other Skills and Abilities:

• Basic understanding of refrigeration principles and fluid dynamics.

• Ability to apply analytical reasoning and root cause analysis to solve problems.

• Demonstrated math and science skills.

• Demonstrated ability to read, understand, interpret and apply technical writing and instruction.

• Strong communication skills; both verbal and written.

• Working knowledge of MS Office, with an emphasis in working with excel.

• Ability to work well independently or as a team.

• Ability to work at heights.

Other Qualifications:

Must pass background check

Must pass drug screen

Physical Demands:

While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to sit and use hands to finger, handle, or feel. The employee is occasionally required to stand; walk; reach with hands and arms; climb or balance and 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.

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.

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 to perform any other job-related duties requested by any person authorized to give instructions or assignments. All duties and responsibilities are essential functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. 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.

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