Validation Technician II - Cleaning and Process Validation

AMERICAN REGENT, INC.; New Albany (OH); Vor Ort; USD 60.000 - 85.000; Vollzeit

Zusammenfassung

American Regent, Inc. seeks a Validation Technician II to oversee validation protocols for equipment and utilities in sterile drug product manufacturing. You will execute IQ/OQ/PQ protocols, generate final reports, and support deviations investigation under supervision.

The role requires strong MS-Office skills, technical writing ability, and the capacity to work independently with minimal supervision. Compliance with FDA/cGMP and safety requirements is essential.

Qualifikationen

• High School Diploma or GED Equivalent and 2 years of relevant work experience required.
• Associate’s degree and 1 year of relevant work experience or Bachelor’s Degree in Life Science, Engineering or 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.

Aufgaben

• Assist in developing validation protocols (IQ, OQ, PQ) and coordinate protocol approval.
• Improve processes and procedures and resolve problems.
• Draft SOPs and Training Modules for the department.
• Support monitoring programs and assist with training of personnel.
• Plan and coordinate validation project activities and protocol execution.
• Perform execution of protocols and produce report summaries.
• Analyze validation data to ensure it meets acceptance criteria.
• Coordinate requalification events and input for deviations.

Kenntnisse

MS Office

Technical writing

Communication

Planning

Independent work

Thermal mapping

Problem solving

Ausbildung

Associate’s degree in Life Science or Engineering

Bachelor’s Degree in Life Science or Engineering

Tools

Kaye Validator 2000

Ellab Val Suite Software

ValGenesis

Jobbeschreibung

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/fmlin.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

American Regent Inc. endeavors to make https://careers.americanregent.com/ 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 [e-mail].

Our values define who we are. They are the fundamental beliefs of our organization and guide our actions and behavior. They influence the way we work with each other, the way we serve our clients, and the way we engage with our communities. Supporting patient health and enhancing the quality of life for animals are our guiding principles.

Our promise is to provide the healthcare marketplace with a steady supply and broad portfolio of branded and generic specialty injectables.

American Regent, Inc., a Daiichi Sankyo Group Company, is a top-10 injectable manufacturer.

For over 50 years, we have been developing, manufacturing, and supplying high-quality generic and branded injectables for healthcare providers and veterinarians across the United States and Canada.

For 20 years, American Regent has been a leader in IV iron therapy and we supply two of the top-selling brands in the US today.

For over 30 years, we have supplied the leading joint health products for horses and dogs.

We have locations in New York, Ohio, and California and sales territories nationwide.