at Meridian Bioscience in Memphis, Tennessee, United States
Meridian Bioscience is a first-choice solution partner of innovative immunological and molecular raw materials that accelerate diagnostic assay development. We are looking for talented and passionate professionals to help drive our vision. Our innovative culture will allow interested candidates to discover and create, through collaboration, novel solutions to tough problems.
The Validation Technician I is responsible for the execution of validation studies. They will conduct and document validation Protocols for equipment and analytical methods according to written protocols. Data will be compiled in written reports for review and approval by area supervisor.
Knowledge, Skills and Abilities:
+ Execute validation protocols according to cGMPs, QSR, and ISO. Maintain schedule established by supervisor.
+ Acquire and assemble equipment and supplies. Accurately collect, document and communicate data.
+ Maintain equipment required for Validation studies in a state of readiness and ensure that it is cleaned, calibrated, and certified prior to use.
+ Coordinate outside vendor activities relating to validations.
+ Assist with required calibrations, either performing as needed or assisting with contractors.
+ Assist senior colleagues with completion of ongoing validation studies as needed and requested.
+ Maintain written and electronic records for executed studies.
+ Collaborate with other departments to complete project requirements. Notify all team members of developments related to equipment under validation.
+ Assure validation equipment and instrumentation is cleaned, maintained and calibrated or certified before use.
+ Submit executed validation studies and draft reports for review.
+ Advise supervisor of any unforeseen occurrences and suggest ideas for improvement.
+ Experience working with diverse laboratory instruments.
+ Familiarity with purified water systems, fermenters, and sterilization equipment is a plus.
+ Working knowledge of cGMPs and Good Documentation Practices.
+ Experience with data collection and reporting.
+ Good Communication and Technical Writing skills.
+ Proficient with MS Word and Excel (MS Project familiarity is preferable).
+ Proficient with MasterControl. Experience with Blue Mountain Regulatory Asset Manager is desirable.
+ Familiarity with laboratory safety principles (BSL-2).
+ Ability to work independently with minimal supervision. Ability to multitask while maintaining attention to detail.
+ Other duties as requested by management.
Education and Experience:
+ Bachelor of Science and 0-1 years experience conducting validation or calibration of laboratory instruments in a regulated environment.
+ No travel is anticipated.
+ Ability to walk up and down several flights of stairs throughout the workday in a multi-location facility.
+ Ability to work on a PC including repetitive use of a keyboard and mouse for long periods throughout the course of the workday.
+ Must be able to lift up to 40lbs. multiple times daily.
+ May be required to work outside normal business hours including evenings and/or weekends to support business needs.
+ Stands for long periods of time.
+ Work in Laboratory Environment.
+ Must be able to climb ladder.
Company: Meridian Life Science, Inc.
External Company Name: Meridian Bioscience, Inc.
External Company URL: www.meridianbioscience.com
Street: 5171 Wilfong RoadTo view full details and how to apply, please login or create a Job Seeker account