Validation Technician II - Cleaning and Process Validation
Validation Technician II - Cleaning and Process Validation
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Salary Not Disclosed
1 Vacancy
Job Description
The Validation Technician II is responsible for validation equipment preparation protocol and final report generation as directed. This position will be primarily responsible for the 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 managements 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.
- Improve processes and procedures and demonstrate initiative in resolving problems.
- Drafts department SOPs and Training Modules.
- Supports monitoring programs and is responsible for assisting with training of personnel.
- Plan and coordinate validation project activities including protocol and work schedules.
- Perform the of protocols and produce report summaries.
- Analyze validation test data to ensure the data meets predefined acceptance criteria.
- Performs specific validationsrelated tasks for Manufacturing equipment as assigned by Supervisor.
- Providing technical support in terms of troubleshooting and participating in the implementation of change controls and correctivepreventive 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.
Education Requirements and Qualifications
To perform this job successfully an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge skill and/or ability required.
- High School Diploma or GED Equivalent and 2 years of relevant work experience required.
- Associates and 1year relevant work experience or Bachelors Degree in Life Science Engineering or a related field required.
- Strong knowledge of MSOffice software and PC Skills required.
- Good scientific technical writing skills.
- Excellent written and verbal communication problemsolving 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 Ellab (Val Suite Software) ValGenesis.
- Ability to work overtime as needed; specifically off hours and weekends.
Physical Environment and 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.
- Employee must be able to occasionally lift and/or move up to 25 pounds.
American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin disability status or protected veteran status.
Applicants have rights under Federal Employment Laws.
- FMLA poster: Your Rights: Know Your Rights: Workplace discrimination is illegal
- Employee Polygraph Protection Act: Regent Inc. endeavors to make accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process please email .
Required Experience:
IC
Employment Type
Full-Time
