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General Description

Andelyn Biosciences is an industry leading cGMP production facility dedicated to advancing the field of gene therapy. Our mission is to use our knowledge, resources, technology, and experience in translational and regulatory science, to develop new, safe, and effective long-term treatments for diseases. There is no disease too rare and no challenge too difficult, as we strive to make a difference with every product and to leave hope in the minds of every patient and family. Andelyn is primarily a full-service manufacturer of Adeno Associated Viruses (AAV).  We work with over 100 clients each year to manufacture AAV at development, toxicology, clinical and commercial quality.

The primary role of the Maintenance Technician I is to provide effective maintenance support to Manufacturing, Research, QC, and laboratory operations. The ability to perform work safely and execute the maintenance program process is paramount. The technician must identify, troubleshoot, and repair problems in all areas of mechanical systems that occur in the facility. The technician must be able to troubleshoot, identify and remediate equipment issues. The technician performs preventive maintenance activities, provides on-call services when required, and is responsible for accurate GMP documentation.

Schedule:  Fulltime (Benefits Eligible)

Locations: 

Manufacturing site                      Andelyn Development Center

1180 Arthur E Adams Drive        5185 Blazer Parkway

Columbus, OH 43221                 Dublin, OH 43017

Principal Duties and Responsibilities

·       Responsible for maintaining all manufacturing equipment including lab, processing equipment, and plant utility system ancillaries including, air compressors, heating, ventilating, steam boilers, and air conditioning systems (HVAC), and upkeep of the physical plant including clean rooms, offices, and building roofing

·        Provide effective troubleshooting support and utilization of equipment to diagnose malfunctions.

·        Continuously maintains proficiency in facility and manufacturing equipment, automation, and controls systems

·        Communicate with peer team members in daily maintenance processes

·        Participate in the department and/or company-wide small-sized projects designed to improve the reliability and predictability of operational processes

·      Cultivates a diverse and collaborative team environment. Utilizes clear and concise communication to deliver high productivity and contribution to the success of department goals

·        Utilize the computerized maintenance management system (CMMS) as necessary to maintain maintenance procedures and accurate equipment historical records

·        Adhere to Good Manufacturing Practices (GMPs) in the execution of the work schedule and operational support Order parts and components for jobs as needed

·        Test new procedures for accuracy and completeness

·        Document repairs, adjustments, and replacement of equipment and or components per cGMP and CDC standards as well as in accordance with relevant procedures

·        Provide after hours on call support, as needed

·        Coordinate with outside contractors

·        Oversee work and paperwork submitted by maintenance vendors as required as well as assign tasks and provides direction

·        Ability to work through GMP processes for equipment failures

·        Exercises crucial people skills

·        Exercise discretion, judgment, and personal responsibility

·        Demonstrate high level of integrity

·        Maintain positive attitude

·        Operate within the Quality Management System applicable to the manufacture of phase appropriate material in the CMF

·        Maintain compliance with applicable regulatory requirements for cellular and gene therapy products

·        Attention to detail in all job functions

·        Performs in accordance with established policies, procedures, and techniques and requires training common experience or working knowledge related to the tasks performed

·        Identifies problems and performs tasks as assigned

·        Work under general supervision of supervisory, senior staff, and leadership

·        Works in diverse and collaborative team environment utilizing clear communication to deliver high productivity and contributes to the success of team and goals

·        Documentation of all activities performed according to SOPs

·        Make decisions based on established procedures

·        Nominal fiscal responsibility

·        Other duties as assigned

Knowledge, Skills, and Abilities Required

·        AS Degree in an Engineering discipline or 2 years of related experience with HS Diploma or equivalent

·        At least 1 years of experience in pharmaceutical, biopharmaceutical or other regulated industry

·        Knowledge of electrical and mechanical principals, including general maintenance practices

·        Ability to read and translate the information within mechanical and electrical schematics and P&ID process diagrams

·        Ability to read and interpret documents, such as safety rules, SOPs, operating and maintenance instructions and procedure manuals

·        Ability to write reports, procedures, work orders and PM descriptions

·        Knowledge of Process Control and Instrumentation Systems

·        Knowledge of HVAC systems such as air handlers, chillers, heat exchangers

·        Ability to complete job assignments simple in nature, requiring planning, project technical execution, and communication to be successful in meeting objectives

·        Experience with process systems and equipment such as filters, pumps, tanks, mixers, autoclaves, fillers, clean rooms labeling equipment, etc.

·        Knowledge of Plant Utility systems and equipment such as pumps, compressors, chillers, boilers, etc.

·        Knowledge of OSHA requirements and understanding of cGMP, GDP, and FDA requirements as they apply to the processing

·        Working knowledge of team function within the organization

·        Excellent communication, organization, and project management skills with the ability to manage multiple projects efficiently and adjust as priorities change

·        Proficient in Microsoft Office (PowerPoint, Excel, Word) including data interpretation and reporting

·        Ability to work independently as well as collaboratively in a diverse and inclusive work environment

·        Must possess a client-focused mindset in daily tasks

·        Must possess prior experience handling confidential information and the ability to maintain confidentiality

 Minimum Physical Requirements 

·        Occasionally Sitting

·        Frequently Walking/Standing/Stooping

·        Independently lifting up to 50 pounds

·        Occasionally Talking on phone or in person

·        Frequently Typing on a computer keyboard

·        May require the ability to aseptically gown or wear other PPE on a regular basis                                                          

                                                                                

The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this classification.  It is not to be construed as an exhaustive list of duties performed by the individual notified, nor is it intended to limit or modify the right of any supervisor to assign, direct, and control the work of employees under his/her supervision.    

 

Andelyn Biosciences is committed to a diverse and inclusive workplace. Andelyn is an equal opportunity employer and does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status.