Job Details

POSITION SUMMARY:

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. Establishes that all computerized systems are functioning as intended and designed. Ensures that all written procedures and practices are in place for computerized systems and serves as primary support for QC and Technical Support laboratories for analytical method development, problem solving and validation in addition to leading equipment validation.

ROLES & 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.

QUALIFICATIONS – EDUCATION, WORK EXPERIENCE, CERTIFICATIONS:

• 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

KNOWLEDGE, SKILLS, AND ABILITIES:

• 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

ACCOUNTABILITY:

• 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.

COMPLEXITY:

• 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.

REQUIRED KNOWLEDGE:

• Laboratory testing of pharmaceuticals
• Pharmaceutical manufacturing processes and procedures
• Computerized systems
• cGMPs, including post-marketing requirements (e.g., pharmacovigilance)

TRAVEL REQUIREMENTS & WORKING CONDITIONS:

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job
• While performing the duties of this job, the employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel; write; type; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; talk or hear; and smell
• Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus