VALIDATION SCIENTIST

MISSION PHARMACAL CO•Boerne, TX

15h

About The Position

This position supports activities within Technical Services including change control, validations, and qualifications. It also supports manufacturing operations by investigating and writing reports for manufacturing investigations, non-conformances, and deviations.

Requirements

Bachelor’s degree from a four-year college or university; preferably in engineering, chemistry, or applied science.
Three years’ experience in the pharmaceutical, biopharmaceutical, or manufacturing industry.
Ability to read and understand scientific and technical documents, such as policy manuals, safety rules, operating and maintenance instructions, and procedure manuals.
Ability to write routine reports and correspondence.
Ability to 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.
Ability to define problems, collect data, establish facts, and draw valid conclusions.
Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
Ability to respond to complex or difficult inquiries or complaints from customers, regulatory agencies, or members of the business community.
Ability to deal with problems involving several known variables in situations of a routine nature.

Nice To Haves

Relative work experience can be substituted in lieu of a college degree.

Responsibilities

Prepare Installation Qualifications (IQ), Operational Qualifications (OQ), Performance Qualifications (PQ), and Re-Qualifications for new or modified manufacturing and laboratory equipment and systems.
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.
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.
Conduct comprehensive audits of qualification processes to ensure strict compliance with internal policies and regulatory requirements.
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.
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.
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.
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.
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.
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).