Job Attributes

Job ID

2251

Location

New Albany, OH

Category

Manufacturing/Production/Operations

Department

Manufacturing

Business Unit

Ohio

Validation Technician

In New Albany, OH

American Regent, Inc., a Daiichi Sankyo Group Company, develops, manufactures, and supplies high quality sterile injectables for healthcare providers, clinics, hospitals and veterinary practices across the United States and Canada. We have locations in New York, Ohio, and Pennsylvania and sales territories nationwide. 

Nature and Scope

The Validation Technician is responsible for validation equipment preparation, protocol execution and final report generation as directed. This position will be primarily responsible for the execution of protocols associated with the installation, operation qualification and requalification of equipment, and utilities used in the analysis and manufacture of sterile pharmaceutical drug products. 

Essential Duties and Responsibilities

Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.  

· Assist in the development of validation protocols
(IQ, OQ, PQ) and coordinate protocol approval. 

· Plan and coordinate validation project
activities including protocol execution and work schedules.  

· Perform the execution of protocols and produce
report summaries. 

· Analyze validation test data to ensure the data
meets validation criteria.  

· Validation technicians apply validation
methodologies to complete tasks, perform installation and operational
activities, produce representative summary reports, and may work under the
direction of supervisor/lead or independently depending upon experience with
activities.  

· Assist Validation and QA to track and coordinate
requalification events. 

· Provide assistance and input to address
validation deviations.  

· Ensures all work is performed and documented in accordance
with existing Company policies and procedures, as well as cGMP and health and
safety requirements.  

· Perform
any other tasks/duties as assigned by management. 

Qualifications and Requirements

· Associate’s or Bachelor’s Degree in Life
Science, Engineering or a related field preferred. 

· Minimum 1 year of experience in a related
field/experience preferred.  

· Strong knowledge of MS-Office software and PC
Skills required. 

· Good technical writing skills.  

· Excellent written and verbal communication,
problem-solving, planning and organization skills 

· Ability to work independently with minimum
supervision, including managing priorities that are in alignment with
departmental and site directives. 

· Experience in executing thermal mapping
protocols is preferred. 

· Validation specific equipment expertise
preferred: Kaye Validator 2000 

· Ability to
work overtime as needed; specifically off hours and weekends. 

Physical Environment and Physical Requirements

· Physically able to wear cleanroom/protective gowning and equipment, including
but not limited to gowning, goggles, face shields, and protective
gloves. PPE is essential for the health and safety of employees.    

We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.  

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HEAR FROM OUR TEAM MEMBERS

"American Regent offers a wonderful work environment with opportunities for growth and advancement. I am also so thankful for the team atmosphere that exists here."

Mary Jean

Customer Service Manager

HEAR FROM OUR TEAM MEMBERS

"American Regent offers a wonderful work environment with opportunities for growth and advancement. I am also so thankful for the team atmosphere that exists here."

Mary Jean

Customer Service Manager
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