Validation Technician II - Cleaning and Process Validation

American Regent, Inc.; New Albany (OH, IN); On-site; USD 45,000 - 75,000; Full time

Job summary

An established industry player is seeking a Validation Technician II to ensure the quality and compliance of sterile pharmaceutical products. This role involves preparing validation protocols, executing tests, and generating reports while adhering to FDA and cGMP guidelines. The ideal candidate will possess strong technical writing and communication skills, along with experience in validation processes. Join a diverse and inclusive team dedicated to excellence in pharmaceutical manufacturing, where your contributions will directly impact product quality and safety. If you're passionate about quality assurance and eager to make a difference, this opportunity is perfect for you.

Qualifications

• 2 years of relevant work experience required.
• Strong knowledge of MS-Office software and good writing skills.

Responsibilities

• Assist in developing validation protocols and coordinate approval.
• Perform protocol execution and produce report summaries.

Skills

MS-Office Software

Scientific Technical Writing

Problem-Solving

Communication Skills

Planning and Organization

Education

High School Diploma or GED

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

Job description

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

American Regent Inc. endeavors to make https://americanregent.com/Careers 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].