Validation Technician II - Cleaning and Process Validation

American Regent, Inc. • New Albany, OH

8d • Onsite

About The Position

The Validation Technician II 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. This position will report into the Validation Supervisor.

Requirements

• High School Diploma or GED Equivalent and 2 years of relevant work experience required.
• Associate’s and 1-year relevant work experience or Bachelor’s Degree in Life Science, Engineering or a related field required.
• Strong knowledge of MS-Office software and PC Skills required.
• Good scientific 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.
• Ability to work overtime as needed; specifically, off hours and weekends.

Nice To Haves

• Experience in executing thermal mapping protocols is preferred.
• Validation specific equipment expertise preferred: Kaye Validator 2000, Ellab (Val Suite Software), ValGenesis.

Responsibilities

• Assist in the development of validation protocols (IQ, OQ, PQ) and coordinate protocol approval.
• Improve processes and procedures and demonstrate initiative in resolving problems.
• Drafts department SOP’s and Training Modules.
• Supports monitoring programs and is responsible for assisting with training of personnel.
• 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 pre-defined acceptance criteria.
• Performs specific validations-related tasks for Manufacturing equipment as assigned by Supervisor.
• Providing technical support in terms of troubleshooting and participating in the implementation of change controls and corrective-preventive actions as a result of investigations related to deviations.
• 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.
• 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, FDA guidance requirements, as well as cGMP and health and safety requirements.
• Perform any other tasks/duties as assigned by management.

Benefits

• FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf
• Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)
• Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level