Validation Specialist II

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 as qualification 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 SOP’s to reflect current validated status

Setup and operation of data acquisition devices such as the Kaye Validator and Eupry dataloggers.

Assist as required in troubleshooting validated equipment such as autoclaves, refrigerators, freezers, incubators, labeling equipment, etc.

Maintain oversight of the 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

A minimum of a 2 or 4 year degree, 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 to the Human Drug 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