Maintenance Technician I
Company: Andelyn Biosciences
Location: Columbus
Posted on: January 27, 2023
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Job Description:
It's an exciting time to join us! General DescriptionAndelyn
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 Center1180 Arthur E Adams
Drive 5185 Blazer ParkwayColumbus, OH 43221 Dublin, OH
43017Principal 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 assignedKnowledge, 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. Andelyn Biosciences is currently operating under
Executive Order 14042 that requires that employees of federal
contractors and its affiliates be vaccinated against COVID-19, with
some limited exemptions under the law. As Andelyn is both an
affiliate and will be a federal contractor, proof of vaccination
status will be required prior to the first date of employment.
Religious and medical exemptions may be considered depending upon
the specific job duties and in accordance with applicable federal
guidelines.
Keywords: Andelyn Biosciences, Columbus , Maintenance Technician I, Professions , Columbus, Ohio
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