Validation Technician II - Cleaning and Process Validation

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.

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.
• 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.

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.

• 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.
• 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: 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

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·Our recruiting process includes multiple in person and/or video interviews and assessments.

·If you are unsure about the legitimacy of a message, contact John Rossini at

jrossini@americanregent.com

 before responding.

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