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Manufacturing Associate I

Aesculap Biologics

This is a Contract position in Lehigh County, PA posted April 24, 2019.

Aesculap Biologics Requisition ID 2018-13622 Company Aesculap Biologics of Openings 1 Job Locations US-PA-Breinigsville Category Other Position Type Regular Full-Time Shift 8 am to 5 pm Site Aesculap Biologics 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.

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 Equal Opportunity Employer Minorities /Women/ Veterans/Disabled.

Through its “Sharing Expertise®” initiative, B.

Braun promotes best practices for continuous improvement of healthcare products and services.

Other Responsibilities: Other Duties: The preceding functions have been provided as examples of the types of work performed by employees assigned to this position.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

The requirements listed in this description are representative of the knowledge, skill, and/or ability required.

Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons.

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.

Work Environment: This position could require the handling of instruments that may or may not have been contaminated by blood or other body fluids.

In compliance with Occupational Safety and Health Administration (OSHA) regulations, Aesculap will provide a safe working environment for all employees.

The noise level in the work environment is usually moderate.

The work environment characteristics described here 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 noise level in the work environment is usually moderate.