PharmaForce, Inc. is a pharmaceutical research, development and manufacturing company based in the Columbus, Ohio area specializing in the sterile injectable market. PharmaForce is wholly owned by parent company, Luitpold Pharmaceuticals, a division of Japanese pharmaceutical company Daiichi Sankyo. We are an Equal Opportunity Employer (Minority/Female/Veterans/Individuals with Disabilities).
Nature and scope
The Validation Technician is an entry-level position 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.
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.
• We all must embrace the QUALITY culture.
• Associates Degree preferred.
• Minimum 2 years 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
• While performing duties of the job, incumbent is occasionally required to stand; walk; sit; use hands to finger, handle or feel objects, tools or controls; reach with hands and arms; balance; talk and hear.
• 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.