26 days old

Manufacturing Associate I

Aesculap Biologics
Breinigsville, PA 18031
  • Job Code
    118872363
Aesculap Biologics


Manufacturing Associate I

US-PA-Breinigsville

Job ID: 2020-16124
Type: Regular Full-Time
# of Openings: 1
Category: Manufacturing
Aesculap Biologics LLC

Overview

Aesculap Biologics, LLC, was established in January 2012 as a division of Aesculap, Inc. and is focused on biological approaches to the repair and regeneration of diseased or damaged tissues. Using a combination of cells, growth factors and smart biomaterial devices, Aesculap Biologics products can stimulate and support the synthesis of new tissue and enhance the body's own regenerative power to improve the quality of patients lives.



Responsibilities

Position Summary:

Required to perform processes and procedures for the manufacture of human cellular products in an aseptic cleanroom environment and in compliance with cGMP/GTP. This position is responsible for product safety and quality and has a direct impact on patient safety. All job functions must be carried out responsibly, competently and conscientiously to ensure that Biologics' products are safe and effective.

Responsibilities: Essential Duties

  • Performs routine procedures following written instructions (SOPs, batch records, protocols, etc.) in support of manufacturing cell therapy product of acceptable quality in compliance with FDA and state regulatory requirements including but not limited to human tissue processing, cell expansion, cell feeding, counting, cryopreservation, harvesting and product seeding.
  • Performs and documents all operations according to good aseptic techniques, current Good Manufacturing, Good Tissue and Good Documentation Practices.
  • Maintains, prepares, cleans, and disinfects manufacturing areas and manual, semi-automated and automated equipment. Maintains required record keeping of equipment cleaning, disinfection and use.
  • Prepares sterile solutions, process reagents, and media in support of aseptic manufacturing processes.
  • Reports Manufacturing and Quality Control discrepancies and deviations as necessary and participates in Corrective and Preventive Action investigations.
  • Inputs data into computerized databases and records process step performance in written batch records and concurrently with operations.
  • Assists in validating and calibrating equipment used for processing.
  • Assists in collecting data for QA, QC, and Development reports.
  • Maintains compliance with GMP reporting requirements and regulatory policies.
  • Performs tasks assigned by the Supervisor or Manager such as maintaining equipment lists, ordering supplies and/or equipment, ordering documents from Document Control, etc.
  • Ability to be gown certified for cleanroom work as needed within 3 months of hire and semi-annually thereafter
  • May interact with auditors and federal and state health authorities during inspections.
  • This position has a direct impact on product and patient safety.
  • This position may be exposed to potentially contaminated tissue, blood or other bodily fluids. In compliance with Occupational Safety and Health Administration (OSHA) regulations, Aesculap will provide required training and a safe working environment for all employees
  • Must comply with applicable ISO and FDA regulations as stated in Quality Manual
  • Must embody the Company's Vision, Mission and Values
  • Must be flexible to work holidays as needed
  • Position requires weekend shifts
  • Other duties may be assigned

Expertise: Knowledge & Skills

  • 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. Ability to speak effectively before groups of customers or employees of organization.
  • Mathematical Skills: Ability to add, subtract, multiply, divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.
  • 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.



Qualifications

Expertise: Qualifications-Experience/Training/Education/Etc


Required:

  • Bachelor's degree in Biology or related field is required.
  • 1-3 years experience in cell culture processing is required.
  • Must have strong organizational and communication skills.
  • Must be detail oriented.
  • Requires computer skills (Word, Excel), and use of a calculator.
  • Must have ability to process, analyze and present data.
  • Excellent oral and written communication skills required.
  • Must be able to work effectively in a team environment.

Desired:

  • Cell therapy experience is a plus.
  • Some knowledge of GMP/GTP regulations is preferred.

While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds.

B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com..

Through its “Sharing Expertise®” initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.



All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.

PI118872363

<strong>Aesculap Biologics</strong><br /><br /><br /><strong>Manufacturing Associate I</strong><br /><br />US-PA-Breinigsville<br /><br /><strong>Job ID:</strong> 2020-16124<br /><strong>Type:</strong> Regular Full-Time<br /><strong># of Openings:</strong> 1<br /><strong>Category:</strong> Manufacturing<br />Aesculap Biologics LLC<br /><br /><strong>Overview</strong><br /><br /> <p style="margin: 0px;"> </p> <p style="margin: 0px;"><span style="font-family: times new roman,times;">Aesculap Biologics, LLC, was established in January 2012 as a division of Aesculap, Inc. and is focused on biological approaches to the repair and regeneration of diseased or damaged tissues. Using a combination of cells, growth factors and smart biomaterial devices, Aesculap Biologics products can stimulate and support the synthesis of new tissue and enhance the body's own regenerative power to improve the quality of patients lives.</span></p> <p style="margin: 0px;"> </p> <br /><br /><strong>Responsibilities</strong><br /><br /> <p style="margin: 0px;"> </p> <p style="margin: 0cm 0cm 10pt;"><span style="font-family: times new roman,times; font-size: 10pt;"><strong>Position Summary:</strong></span></p> <p style="margin: 0cm 0cm 10pt;"><span style="font-family: times new roman,times; font-size: 10pt;">Required to perform processes and procedures for the manufacture of human cellular products in an aseptic cleanroom environment and in compliance with cGMP/GTP. This position is responsible for product safety and quality and has a direct impact on patient safety. All job functions must be carried out responsibly, competently and conscientiously to ensure that Biologics' products are safe and effective.</span></p> <p style="margin: 0cm 0cm 10pt;"><span style="font-family: times new roman,times; font-size: 10pt;"><strong>Responsibilities: Essential Duties</strong></span></p> <ul> <li style="color: #000000; font-family: 'Times New Roman','serif'; font-size: 10pt;"><span style="font-family: times new roman,times; font-size: 10pt;">Performs routine procedures following written instructions (SOPs, batch records, protocols, etc.) in support of manufacturing cell therapy product of acceptable quality in compliance with FDA and state regulatory requirements including but not limited to human tissue processing, cell expansion, cell feeding, counting, cryopreservation, harvesting and product seeding.</span></li> <li style="color: #000000; font-family: 'Times New Roman','serif'; font-size: 10pt;"><span style="font-family: times new roman,times; font-size: 10pt;">Performs and documents all operations according to good aseptic techniques, current Good Manufacturing, Good Tissue and Good Documentation Practices.</span></li> <li style="color: #000000; font-family: 'Times New Roman','serif'; font-size: 10pt;"><span style="font-family: times new roman,times; font-size: 10pt;">Maintains, prepares, cleans, and disinfects manufacturing areas and manual, semi-automated and automated equipment. Maintains required record keeping of equipment cleaning, disinfection and use.</span></li> <li style="color: #000000; font-family: 'Times New Roman','serif'; font-size: 10pt;"><span style="font-family: times new roman,times; font-size: 10pt;">Prepares sterile solutions, process reagents, and media in support of aseptic manufacturing processes.</span></li> <li style="color: #000000; font-family: 'Times New Roman','serif'; font-size: 10pt;"><span style="font-family: times new roman,times; font-size: 10pt;">Reports Manufacturing and Quality Control discrepancies and deviations as necessary and participates in Corrective and Preventive Action investigations.</span></li> <li style="color: #000000; font-family: 'Times New Roman','serif'; font-size: 10pt;"><span style="font-family: times new roman,times; font-size: 10pt;">Inputs data into computerized databases and records process step performance in written batch records and concurrently with operations.</span></li> <li style="color: #000000; font-family: 'Times New Roman','serif'; font-size: 10pt;"><span style="font-family: times new roman,times; font-size: 10pt;">Assists in validating and calibrating equipment used for processing.</span></li> <li style="color: #000000; font-family: 'Times New Roman','serif'; font-size: 10pt;"><span style="font-family: times new roman,times; font-size: 10pt;">Assists in collecting data for QA, QC, and Development reports.</span></li> <li style="color: #000000; font-family: 'Times New Roman','serif'; font-size: 10pt;"><span style="font-family: times new roman,times; font-size: 10pt;">Maintains compliance with GMP reporting requirements and regulatory policies.</span></li> <li style="color: #000000; font-family: 'Times New Roman','serif'; font-size: 10pt;"><span style="font-family: times new roman,times; font-size: 10pt;">Performs tasks assigned by the Supervisor or Manager such as maintaining equipment lists, ordering supplies and/or equipment, ordering documents from Document Control, etc.</span></li> <li style="color: #000000; font-family: 'Times New Roman','serif'; font-size: 10pt;"><span style="font-family: times new roman,times; font-size: 10pt;">Ability to be gown certified for cleanroom work as needed within 3 months of hire and semi-annually thereafter</span></li> <li style="color: #000000; font-family: 'Times New Roman','serif'; font-size: 10pt;"><span style="font-family: times new roman,times; font-size: 10pt;">May interact with auditors and federal and state health authorities during inspections.</span></li> <li style="color: #000000; font-family: 'Times New Roman','serif'; font-size: 10pt;"><span style="font-family: times new roman,times; font-size: 10pt;">This position has a direct impact on product and patient safety.</span></li> <li style="color: #000000; font-family: 'Times New Roman','serif'; font-size: 10pt;"><span style="font-family: times new roman,times; font-size: 10pt;">This position may be exposed to potentially contaminated tissue, blood or other bodily fluids. In compliance with Occupational Safety and Health Administration (OSHA) regulations, Aesculap will provide required training and a safe working environment for all employees</span></li> <li style="color: #000000; font-family: 'Times New Roman','serif'; font-size: 10pt;"><span style="font-family: times new roman,times; font-size: 10pt;">Must comply with applicable ISO and FDA regulations as stated in Quality Manual</span></li> <li style="color: #000000; font-family: 'Times New Roman','serif'; font-size: 10pt;"><span style="font-family: times new roman,times; font-size: 10pt;">Must embody the Company's Vision, Mission and Values</span></li> <li style="color: #000000; font-family: 'Times New Roman','serif'; font-size: 10pt;"><span style="font-family: times new roman,times; font-size: 10pt;">Must be flexible to work holidays as needed</span></li> <li style="color: #000000; font-family: 'Times New Roman','serif'; font-size: 10pt;"><span style="font-family: times new roman,times; font-size: 10pt;">Position requires weekend shifts</span></li> <li style="color: #000000; font-family: 'Times New Roman','serif'; font-size: 10pt;"><span style="font-family: times new roman,times; font-size: 10pt;">Other duties may be assigned</span></li> </ul> <p style="margin: 0cm 0cm 10pt;"><span style="font-family: times new roman,times; font-size: 10pt;"><strong>Expertise: Knowledge & Skills</strong></span></p> <ul> <li style="color: #000000; font-family: 'Times New Roman','serif'; font-size: 10pt;"><span style="font-family: times new roman,times; font-size: 10pt;"><strong>Language Skills:</strong> Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization.</span></li> <li style="color: #000000; font-family: 'Times New Roman','serif'; font-size: 10pt;"><span style="font-family: times new roman,times; font-size: 10pt;"><strong>Mathematical Skills:</strong> Ability to add, subtract, multiply, divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.</span></li> <li style="color: #000000; font-family: 'Times New Roman','serif'; font-size: 10pt;"><span style="font-family: times new roman,times; font-size: 10pt;"><strong>Reasoning Ability:</strong> 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.</span></li> </ul> <p style="margin: 0px;"> </p> <br /><br /><strong>Qualifications</strong><br /><br /> <p style="margin: 0px;"><span style="font-family: times new roman,times; font-size: 10pt;"><strong>Expertise: Qualifications-Experience/Training/Education/Etc</strong></span></p> <p style="margin: 0cm 0cm 10pt;"><span style="font-family: times new roman,times; font-size: 10pt;"><strong><br />Required:</strong></span></p> <ul> <li style="color: #000000; font-family: 'Times New Roman','serif'; font-size: 10pt;"><span style="font-family: times new roman,times; font-size: 10pt;">Bachelor's degree in Biology or related field is required.</span></li> <li style="color: #000000; font-family: 'Times New Roman','serif'; font-size: 10pt;"><span style="font-family: times new roman,times; font-size: 10pt;">1-3 years experience </span><span style="font-family: times new roman,times; font-size: 10pt;">in cell culture processing is required.</span></li> <li style="color: #000000; font-family: 'Times New Roman','serif'; font-size: 10pt;"><span style="font-family: times new roman,times; font-size: 10pt;">Must have strong organizational and communication skills.</span></li> <li style="color: #000000; font-family: 'Times New Roman','serif'; font-size: 10pt;"><span style="font-family: times new roman,times; font-size: 10pt;">Must be detail oriented.</span></li> <li style="color: #000000; font-family: 'Times New Roman','serif'; font-size: 10pt;"><span style="font-family: times new roman,times; font-size: 10pt;">Requires computer skills (Word, Excel), and use of a calculator.</span></li> <li style="color: #000000; font-family: 'Times New Roman','serif'; font-size: 10pt;"><span style="font-family: times new roman,times; font-size: 10pt;">Must have ability to process, analyze and present data.</span></li> <li style="color: #000000; font-family: 'Times New Roman','serif'; font-size: 10pt;"><span style="font-family: times new roman,times; font-size: 10pt;">Excellent oral and written communication skills required.</span></li> <li style="color: #000000; font-family: 'Times New Roman','serif'; font-size: 10pt;"><span style="font-family: times new roman,times; font-size: 10pt;">Must be able to work effectively in a team environment.</span></li> </ul> <p style="margin: 0cm 0cm 10pt;"><span style="font-family: times new roman,times; font-size: 10pt;"><strong>Desired:</strong></span></p> <ul> <li style="color: #000000; font-family: 'Times New Roman','serif'; font-size: 10pt;"><span style="font-family: times new roman,times; font-size: 10pt;">Cell therapy experience is a plus.</span></li> <li style="color: #000000; font-family: 'Times New Roman','serif'; font-size: 10pt;"><span style="font-family: times new roman,times; font-size: 10pt;">Some knowledge of GMP/GTP regulations is preferred.</span></li> </ul> <p style="margin: 0px;"> </p> <p style="margin: 0cm 0cm 10pt;"><span style="font-family: times new roman,times;">While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds.</span></p> <p style="margin: 0cm 0cm 10pt;"> </p> <p style="margin: 0cm 0cm 10pt;"><span style="font-family: times new roman,times;">B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com..</span></p> <p style="margin: 0cm 0cm 10pt;"><span style="font-family: times new roman,times;">Through its Sharing Expertise initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.</span></p> <p style="margin: 0px;"> </p> <p style="margin: 0px;"> </p> <br /><br />All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status. <img src="https://analytics.click2apply.net/v/5D6GgBIjjmXVs8O6CgX2P"> <p>PI118872363</p>

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Posted: 2020-03-09 Expires: 2020-04-09

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Manufacturing Associate I

Aesculap Biologics
Breinigsville, PA 18031

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