VALIDATION SCIENTIST

Description

GENERAL DESCRIPTION OF POSITION: This position supports validation department goals and objectives by performing equipment qualifications, process validations, cleaning validations, and computerized system validations.

Requirements

ESSENTIAL DUTIES AND RESPONSIBILITIES:

1. Multi-Category Competence: Demonstrate proven knowledge and technical competence across the duties and responsibilities of at least three of the five specified Technical Services (TS) categories. 

2. Equipment and Utility Qualifications: Prepare Installation Qualifications (IQ), Operational Qualifications (OQ), Performance Qualifications (PQ), and Re-Qualifications for new or modified manufacturing and laboratory equipment and systems. 

3. Change Control and Assessment: Gather technical information from Production, Mechanical Maintenance, and Quality Assurance/Quality Control (QA/QC) to prepare Facility/Equipment Change Control Documents. Review part and component replacement documentation to assess the need for qualification, requalification, and change control. 

4. Utility and Environmental Testing: Perform routine testing and report preparation for compressed air systems and particulate air monitoring. Conduct building and stability chamber mapping studies as required. Execute the Annual Review of Purified Water Systems. 

5. Process Auditing: Conduct comprehensive audits of qualification processes to ensure strict compliance with internal policies and regulatory requirements. 

6. Process Validation Program: Prepare, review, and execute process validation, bulk hold, and packaging validation studies. Analyze validation test data to determine if systems or processes successfully meet established validation criteria. 

7. Scientific Support and Collaboration: Assist Validation Scientists with preparing IQ/OQ/PQ protocols for new or modified manufacturing and laboratory equipment. Gather information from Production, Mechanical Maintenance, and QA/QC to generate facility and equipment change control documents. 

8. Reporting and Data Management: Prepare detailed summary reports based on validation test results or protocol reviews, providing actionable recommendations for operations, processes, and methods. Coordinate validation sampling and testing schedules with affected departments. Collaborate with Development Operations to design study features, such as sampling, testing, or analytical methodologies. Draw samples as necessary, prepare Annual Continuous Process Validation Verification Reports, audit validation processes for compliance, and maintain tracking databases. 

9. Computer System Validation (CSV): Prepare, review, and execute spreadsheet validations, developing or modifying spreadsheets for the QC Laboratory as required. Conduct qualification tests on new or modified computer-controlled processes, equipment, or software in accordance with internal protocols and external standards. Develop standard operating procedures (SOPs), process flow diagrams, and test cases, while assisting other departments with software backup maintenance. 

10. Cleaning Validation Program: Prepare, review, and execute cleaning validation studies and participate in protocol execution. Analyze test data against validation criteria, prepare detailed summary reports, and coordinate sampling schedules with affected departments. Conduct routine cleaning validation challenges to ensure program compliance. Partner with Production and Laboratory personnel to determine cleaning limits and clean/dirty hold times and collaborate with Development Operations to evaluate cleaning procedures for new raw materials and products. 

11. Investigations and Risk Management: Review Out of Specification (OOS) and Out of Trend (OOT) results to evaluate their impact on validated processes. Identify deviations from established product or process standards and provide recommendations for resolution. Complete thorough investigations on assigned issues by performing risk assessments, determining containment actions, identifying root causes, and formulating corrective actions (CAPA). 

QUALIFICATIONS, EDUCATION AND EXPERIENCE: Bachelor’s degree from a four-year college or university; preferably in engineering, chemistry, or applied science and three years’ experience in the pharmaceutical, biopharmaceutical, or manufacturing industry. Relative work experience can be substituted in lieu of a college degree.

COMMUNICATION SKILLS: Must be able to (i) read and understand scientific and technical documents, such as policy manuals, safety rules, operating and maintenance instructions, and procedure manuals; (ii) write routine reports and correspondence; (iii) effectively communicate information and respond to questions, orally and in writing, in person-to-person and small group situations with customers, clients, general public and other employees of the organization.

MATHEMATICAL AND CRITICAL THINKING SKILLS: Must be able to (i) define problems, collect data, establish facts, and draw valid conclusions; (ii) possess the ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables; (iii) the ability to respond to complex or difficult inquiries or complaints from customers, regulatory agencies, or members of the business community; and (iv) deal with problems involving several known variables in situations of a routine nature.

PHYSICAL ACTIVITIES: Must be able to occasionally lift and/or move up to 10 pounds; sit, stand and/or walk for periods of time; and exhibit close visual attention to work activities.