Biologics Mfg. Associate / 3311 Job in Breinigsville 18031, Pennsylvania US
Aesculap is the largest worldwide supplier of surgical instruments and implants for all disciplines including neurosurgery, microsurgery, ENT, plastic and reconstructive, thoracic, micro-vascular, cardiovascular, orthopedic, laparascopic, general surgeries and central processing. We were founded in Germany in 1867 and have been in operation in the U.S. since 1977. Our U.S. corporate office is located in Center Valley, Pennsylvania.
Position Description:
Aesculap is the largest worldwide supplier of surgical instruments and implants for all disciplines including spine, neurosurgery, microsurgery, ENT, plastic and reconstructive, thoracic, micro-vascular, cardiovascular, orthopedic, laparascopic, general surgeries and central processing. We were founded in Germany in 1867 and have been in operation in the U.S. since 1977. Our U.S. corporate office is located in Center Valley, Pennsylvania. Aesculap, Inc., has an excellent opportunity for a Manufacturing Associate.
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.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• 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 the development of new procedures and process improvements.
• 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.
• Assists in the creation of SOPs and other manufacturing documentation.
• Troubleshoots manufacturing processes and equipment.
• 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
• Must be flexible to work weekends as needed
• 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
• Other duties may be assigned
SUPERVISORY RESPONSIBILITIES:
Not Applicable.
QUALIFICATIONS:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION/EXPERIENCE:
• Bachelor’s degree in Biology or related field is required.
• 2-4 years experience in cell based manufacturing in cell therapy/biopharmaceutical industry is required.
• Cell therapy experience is a plus.
KNOWLEDGE/SKILLS:
• Requires some knowledge of GMP/GTP regulations.
• Must have strong organizational and communication skills.
• Must be detail oriented.
• Requires computer skills (Word, Excel, Access).
• 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.
LANGUAGE AND MATHEMATICAL SKILLS; REASONING ABILITY:
Language Skill: 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.
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.
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 finger, 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.
WORK ENVIRONMENT:
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.
Aesculap offers an excellent benefits package, which includes healthcare, a 401(k) plan, company sponsored pension and tuition reimbursement. To learn more about Aesculap and to apply for this position, please visit us on the internet at www.aesculapusa.com / www.aesculapimplantsystems.com . An EOE / AA.