Validation Specialist II

Job Description

Job Description

Salary: $65-$80K/yr DOE

Position Summary:

Works collaboratively with the Quality Control and Production Unit to perform routine validation and calibration activities. Assists with onboarding of all new equipment, requalification of existing equipment and all validation activities to include Installation and Operational Qualifications and Performance Qualifications.

Essential Functions:

• Perform and assist with validation activities such as Installation,Operational, Performance Qualifications (IOPQ), and Requalifications (RQ).
• Author and review of technical documents such asqualification protocols, summary reports, and final reports.
• Support computer system validation activities including user acceptance testing, traceability documentation, and validation summary reports.
• Assist in nonconformance investigations, out-of-specification (OOS), and out-of-calibration (OOC) events as they relate to validated systems and equipment.
• Support risk assessment activities associated with equipment qualification, process changes, and revalidation decisions.
• Creation and modification of SOPs to reflect current validated status
• Setup and operation of dataacquisitiondevices such as the Kaye Validator and Eupry dataloggers.
• Assist as required in troubleshooting validated equipmentsuch as autoclaves, refrigerators, freezers, incubators, labelingequipment, etc.
• Maintain oversight ofthe internal calibration tracking program by maintaining the records and alerting key stakeholders of calibration due dates and status
• Collaborate with key stakeholders to assist in new validation initiatives
• Perform other duties assigned by the Director of Engineering and Director of Quality/Production to ensure uniform quality assurance throughout the entire company
• Become gown qualified to perform validation activities in classified environments

Education and Experience:

• A minimum of 1-2 years Validations or equivalent experience
• Aminimum ofa 2 or 4 yeardegree, preferably in a Science or Engineering field of study; or equivalent industry experience.

Knowledge, Skills and Abilities:

• Full knowledge and understanding of FDA cGMP, CFR Parts 210 and 211, USP Chapters / Monographs, and various State Board of pharmacy laws as they relate tothe HumanDrug Compounding.
• Excellent interpersonal communication skills including presentation skills, and multitask ability
• Strong computer skills, knowledgeable with standard Microsoft Office applications and Kaye Validator software
• Self-motivated and organized with minimum supervision
• Cleaning validation experience desirable

Physical Requirements / Working Conditions:

• Prolonged periods standing on production floor
• Prolonged periods of walking
• Must be able to lift up to 35 pounds at times
• Must be able to climb small stepladders
• Must be able to wear appropriate PPE (goggles, gloves, scrubs, frock/coverall, hairnet/hood, beard guard/mask) as needed based on work area and materials being handled in accordance with procedures/policies

Compensation

$65-$80K/yr DOE