Senior Technical Operations Validation Specialist

The Senior Technical Operations Validation Specialist is the subject matter expert (SME) for various types of technical responsibilities which are within the scope and oversight of the pharmaceutical quality unit, encompassing validation of processes, equipment, facilities, cleaning procedures, and computerized systems; commercial support, and research and development support as needed.

• Create validation protocols for processes, equipment, facilities, cleaning procedures, and computerized systems.
• Serves as system administrator and technical SME responsible for ensuring systems are qualified and functioning as intended, process flow of tasks are well designed and efficient, and systems are compliant with regulatory and corporate standards for data integrity and purpose, thus ensuring adequate quality systems and respective written procedures and practices are in place for these computerized systems for the lifecycle, (e.g., change control, validation, coding standards, training, problem reporting, hardware, software and interface operations, system security, electronic records/electronic signatures, audit trail processes, data integrity, etc.).
• Primary technical support for QC laboratories for analytical method development, problem-solving, and validation in addition to leading equipment validation (IQ, OQ, and PQ).
• Configure and test software such as Quality Control Laboratory Information Management System (LIMS), Chromatography Data System (CDS) and other QC computerized systems, maximizing the potential functionality of such systems.
• Prepare and compile data to analyze test information to determine process or equipment operating efficiency or to diagnose malfunctions and write technical papers or reports or prepare standards and specifications for processes, facilities, products or tests.
• Studies chemical compounds and uses research to support the development of products or processes.
• Subject Matter Expert (SME) for supporting risk assessments for any product quality inquiries, calculations of formulation content, and/or supports the assessment of any potentially applicable emerging risks as may be identified within the pharmaceutical industry.
• Liaises with laboratory section managers and other QC personnel, IT and service providers to support questions, resolve problems and provide training as needed.
• Support technical documentation for CMC supplements, Annual Reports, Annual Product Reviews to assist Quality and Regulatory Affairs with maintaining product registrations as needed or requested.
• Assists with evaluation and implementation and validation of identified software for new applications or for replacement.
• Perform other ancillary data management tasks and support performance of any system interfaces as needed.
• Immediately notify lab personnel of any operational challenges or hardware/software system failures so laboratory personnel can take appropriate action.
• Set up/ modify product specifications, test methods, calculations per methods and perform test runs in LIMS and SAP as needed per the change control task lists (using appropriate environments for development, testing and production (when proven and approved)).
• Recommends improvements, ideas or changes to methods and operations as appropriate for cGMP compliance, efficiency, cost and performance.
• Assists with technical writing, e.g., revision of analytical procedures, equipment related SOPs, and results summaries as required, content of drug product registrations, investigations, CAPAs, risk assessments, etc.
• Assists with and carries out other departmental duties as deemed appropriate by Manager to meet the goals, business objectives, and production plans.
• Keeps current with technical and professional literature and compendia, attending technical discussions, and training opportunities as applicable and beneficial.
• Encourages safety first in work practices via guidance from training sessions, chemical hygiene plan, Safety Data Sheets (SDSs), and other technical literature and resources.
• Perform statistical analysis of laboratory and process data to support Annual Product Reviews and Continued Process Verification programs.

• Technical writing, including validation protocols, risk assessments, and SOPs in a FDA-regulated environment
• Problem solving skills
• Ability to perform independent research to provide scientific and technical justification for proposed procedures, processes, or products
• Data analysis skills, including statistical analysis of process and laboratory data for statistical process control and other applications
• Strong computer skills, including word processing, spreadsheets, and application software

• 401k matching
• Health insurance
• Flight privileges

USAntibiotics, the only U.S. manufacturer of Amoxicillin products, is part of the Jackson Healthcare family of companies. We’re always looking to add new talent to our teams, and we value diverse professionals who have strong leadership skills, align with our culture, and are committed to excellence.