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USAntibiotics · 3 weeks ago

Senior Technical Operations Validation Specialist

Bristol, TN

Full-time

Onsite

Senior Level

5+ years exp

USAntibiotics is a pharmaceutical company focused on quality assurance and validation processes. The Senior Technical Operations Validation Specialist will serve as a subject matter expert for validation of technical operations, ensuring compliance with regulatory standards and supporting QC laboratories in analytical method development and validation.

Pharmaceuticals

Hiring Manager

Leslie Worsham, CPC

Responsibilities

Create validation protocols for processes, equipment (IQ, OQ, and PQ), cleaning procedures, facilities, 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 specfications, 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

Qualification

Validation protocolsLIMSAnalytical techniquesCGMP knowledgeData analysisTechnical writingProblem solvingTeamworkCommunication skillsAttention to detail

Required

BS/BA degree in a STEM field; MS or Ph.D. preferred

Experience writing validation protocols covering a range of areas relevant to pharmaceutical manufacturing (minimum 5 years)

Experience with database management and computer coding, LIMS, or other related software systems and analytical experience in pharmaceutical industry preferred or related technical scientific work experience

Experience with analytical techniques, test methodology, method development, method validation calibration and reporting for data integrity in a CGMP/FDA regulated industry

Knowledge of pharmaceutical solid oral dosage form manufacturing processes

Strong knowledge of current Good Manufacturing Practices

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

Scientific theory and analytical methodology and pharmaceutical laboratory practices for accuracy and reliability

Excellent attention to detail and problem-solving skills. Ability to train well and communicate necessary principles and details to others

Appropriate interpersonal (team work) and leadership skills

Strong verbal communication skills and technical writing skills

Ability to recognize possible compliance, technical, or safety-related issues, prioritize and decide appropriate course of action

Ability to suggest appropriate corrective and/or preventive action(s) and execute implementation

Ability to work in a multi-disciplinary team environment and support objectives of the site organization

Demonstrated ability to make good decisions and function independently

Must be knowledgeable of system configuration, operation and validation in order to assure identification of any system compliance issues and be able to respond and minimize system disruptions

Must have knowledge of analytical methodologies and instrumentation and laboratory operations in order to maintain effective computerized systems and problem-solving support to assure proper data treatment, calculations, input of acceptance criteria and other configuration, etc., in LIMS and CDS, etc., to ensure data integrity and the most efficient ways of working

Must be able to multitask and manage multiple projects per established priorities

Must be able to clearly communicate problems and/or objectives with Technical Support, consulting personnel and service providers

Advanced computer skills. SAP experience and related laboratory software experience preferred in addition to the ability to troubleshoot hardware and software configuration issues and to maximize potential of computerized systems

Must have recent relevant experience with regulatory expectations for appropriate data analysis and treatment and use of statistics and other tools for trending and root cause analysis and process improvement

Ability to assess product formulations for content and quality when any potential risk assessments may be indicated

Laboratory testing of pharmaceuticals

Pharmaceutical manufacturing processes and procedures

Computerized systems

cGMPs, including post-marketing requirements (e.g., pharmacovigilance)