Validation Technician

Nature and Scope

The Validation Technician will be responsible for supporting the qualification process of manufacturing equipment,

facility utilities and storage chambers to ensure that all criteria satisfy FDA and cGMP guidelines for facility use.

This position will also perform routine monitoring activities (such as routine monitoring of temperature-controlled

chambers / areas and cleanroom pressure differentials) within the facility.

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.

• Provides support for start-up and ongoing validation activities associated with our cGMP manufacturing facilities.
• Supports the execution of approved protocols, analyze test results applicable to qualifications and also drafts technical reports summarizing qualification activities.
• Prepares revalidation trending packages for various equipment and utilities used for cGMP processes.
• Works with Manufacturing, Research & Development, Maintenance / Metrology, Quality Control and
• Quality Assurance Departments to coordinate qualification activities and resolve any problems which may arise.
• Assists with drafting or revising Standard Operating Procedures (SOPs) as required.
• Performs routine monitoring activities for the facility (includes but is not limited to routine monitoring of validated storage chambers / areas and pressure differential of cleanroom suites).
• Initiates deviations, document change requests, change controls, CAPAs when necessary.
• 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.

• Bachelor degree in field of science; or equivalent combination of education and experience.
• Entry level position, 0 - 1 year of experience required.
• Experience with temperature mapping equipment (Kaye Validator, Ellab, Honeywell Recorders) preferred.
• Experience in a pharmaceutical cGMP manufacturing or compliance environment preferred.
• Experience in aseptic processing operations preferred.
• Technical documentation skills.
• Good verbal, written and interpersonal communication skills.
• Comfortable in a fast-paced small company environment and able to adjust workload based on changing priorities and business needs.
• Ability to think critically with demonstrated troubleshooting and problem-solving skills.
• Proficient with Microsoft Office (Excel, Word, Outlook)2
• Ability to work overtime as needed.

Physical Environment and Requirements

• Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees.
• Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly.
• Employee must be able to occasionally lift and/or move up to 25 pounds.

Expected hourly range:

$22.50 - $25.00

The hourly range displayed is the minimum and maximum hourly rate for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate's qualifications, education, knowledge, skills and experience.

American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide range of other benefits.

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.

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 hrtalentacquisition@americanregent.com.