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Senior Lyophilization Expert

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

Summary:

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 (SOPs) 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 SOPs relating to the department, completes all associated quality reporting documentation.

The Senior Lyophilization Craftsman is a subject matter expert in lyophilization and works within a team to ensure daily responsibilities such as cleaning, sterilizing, and leak testing lyophilizers before product manufacturing. They operate lyophilizers according to specifications, monitor cycles, review data for compliance, and complete necessary 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.

We proudly offer

• Generous benefit options

• Paid training, vacation and holidays

• Career advancement opportunities

• Education reimbursement

• 401k program

• And more!

  Essential Duties and Responsibilities:

• Ensures lyophilizers are cleaned, sterilized and tested for leaks prior to manufacturing of a 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 cGMP, safety practices, and SOPs

• Train newly hired technicians and current technicians as needed

• Serves as the subject matter expert for assisting maintenance and troubleshooting

• Maintain up to date trainings

• Other duties as assigned

  Education and Experience:

• Bachelor’s degree with an emphasis in applied Science or related field of study

• Minimum of eight (8) years’ lyophilization experience

• Minimum of five (5) years’ HVAC and automation mechanical experience

• Minimum of five (5) years related experience in production, manufacturing, and/or cleanroom, preferred

• Minimum of five (5) year experience in a pharmaceutical manufacturing industry or relevant industry, preferred

  Supervisory Responsibilities:

  This role does not have supervisory responsibilities, yet it may involve mentoring, guiding, and advising.

  Language Skills:

  The ideal candidate should have the ability to read and interpret various documents, such as safety instructions, standard operating procedures, technical procedures, and governmental regulations. Additionally, they should possess strong written and verbal communication skills, along with effective presentation skills.

  Mathematical Skills:

  Proficient in executing arithmetic operations including addition, subtraction, multiplication, and division across various units of measurement, employing whole numbers, fractions, decimals, and percentages. Candidates must possess a strong grasp of algebraic and geometric principles.

  Reasoning Ability:

  Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

  Computer Skills:

  The ideal candidate will possess a strong technical foundation and proven capability in effectively utilizing diverse software tools to streamline the organization's daily functions. Essential skills encompass adeptness in manufacturing and internet software, alongside proficiency in Microsoft Office tools including PowerPoint, Excel, Word, and Outlook.

  Other Skills and Abilities:

• Provides guidance and mentorship to team members

• Fosters a collaborative and positive work environment

• Champions change

• Promotes a safe and healthy work environment by actively identifying and addressing potential hazards, following established safety protocols, participating in safety training programs, and fostering a culture of awareness and responsibility among team members.

• Demonstrates strong attention to detail

• Basic understanding of refrigeration principles and fluid dynamics

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

• Ability to work well independently or as a team

• Ability to work at elevated heights

  Other Qualifications:

  Must pass a background check

  Must pass a drug screen

  May be required to pass Occupational Health Screening

  Must be able to obtain and maintain gowning certification

  May be required to wear a respirator

  Physical Demands:

  The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  The essential physical demands will vary for each Curia position.

  All positions may require regular or occasional lifting, pushing and pulling up to 10 pounds, frequently; up to 25 pounds occasionally; and up to 50 pounds infrequently. Additionally, all positions entail regular sitting, standing and reaching, with some roles requiring prolonged periods of time for each activity. Visual acuity, both close and distant, along with depth perception is necessary in each role, with or without corrective lenses. Please note that employees are prohibited from wearing contact lenses in work areas with exposure to cleaning agents. Hand and finger dexterity are integral to all positions, with specific activities varying from typing to manipulating maintenance tools or operating keypads, switches, and buttons. Occasional stooping, kneeling, twisting, crouching, crawling and balancing are also part of each position’s physical requirements. Certain roles may involve climbing and working at elevated heights as well.

  Work Environment:

  The work environment characteristics, described below, are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  The working environments will vary for each Curia position. The employee may be required to work in an office, manufacturing, or warehouse environment.

  The office environment is designed for comfort and productivity, with room temperature settings maintained for optimal working conditions. It is common to hear conversational noise in the background.

  The pharmaceutical manufacturing environment is sterile. Therefore, aseptic gowning is required. Personal protective equipment (nitrile gloves, clean room socks, face-shields, safety glasses, aprons, steel-toed shoes and powered air purifying respirators) is necessary, depending upon the task at hand. The employee may be exposed to wet and/or humid conditions, confined areas, and refrigerator or freezer temperatures when working in a sterile environment.

  The warehouse environment is typically set at a controlled temperature but the employee may be exposed to refrigerator or freezer temperatures when retrieving materials.

  Some positions may occasionally be exposed to moving mechanical parts, elevated heights, airborne particles, electrical activities and vibration. In addition, some positions may work with or be exposed to, compressed gases and must wear ear protection.

  All environments may be subject to working with or being exposed to cleaning agents.

  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 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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