Validation Scientist Resume
Objective : A Validation Scientist plays a crucial role in ensuring that products and processes meet stringent regulatory standards and quality requirements. This position involves designing and executing validation protocols, analyzing data, and documenting results to support compliance with industry regulations. The Validation Scientist collaborates with cross-functional teams to identify validation needs, develop strategies, and implement best practices. Expertise in statistical analysis and quality assurance methodologies is essential, as is a thorough understanding of Good Manufacturing Practices (GMP) and relevant regulatory guidelines.
Skills : Analytical Skills, Attention to Detail, Software Validation, Equipment Qualification, Team Collaboration
Description :
- Assisted with unusual problems, performed assignments that had clear and specific objectives, and required investigation of a limited number of variables.
- Initiated and completed routine technical tasks.
- Functioned as a technical validation expert for equipment or systems regarding troubleshooting operations.
- Cleaned-in-place and Clean-Out-of Place cycle development activities for processing tanks, and cabinet washers including parameter selection, recipe design, determining the order of operations, troubleshooting, sampling, and trend data analysis.
- Audited the validation status and regulatory compliance of a moderate number of equipment items or systems of significant complexity.
- Worked with manufacturing, maintenance, process development, utilities, facilities, labs, and/or quality assurance in developing requirements and recommendations for system modifications.
- Conducted validation studies for analytical methods to ensure compliance with regulatory standards.
Experience
2-5 Years
Level
Executive
Education
PhD Pharm Sci
Validation Scientist Resume
Headline : In the pharmaceutical and biotechnology industries, a Validation Scientist is responsible for validating equipment, processes, and systems to ensure they operate consistently and produce high-quality products. This role requires a deep understanding of validation principles, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). The Validation Scientist must also prepare and review validation documentation, conduct risk assessments, and provide training to staff on validation procedures, ensuring that all activities align with regulatory requirements and industry best practices.
Skills : Technical Writing, Problem-Solving, Data Analysis, Regulatory Compliance, Quality Assurance, Laboratory Techniques
Description :
- Worked under the direct supervision of project managers to complete the validation responsibilities of engineering, and construction projects within schedule and budget constraints.
- Generated rudimentary project cost estimates and schedules.
- Prompted and regularly attendance to the workplace.
- Worked knowledge of validation processes and programs.
- Well-trained with pharmaceutical/biotech processes.
- Familiared with documentation in a highly regulated environment.
- Operated specialized laboratory equipment and computers as appropriate.
Experience
5-7 Years
Level
Executive
Education
BS Chemistry
Validation Scientist Resume
Objective : As a Validation Scientist, applied extensive technical validation expertise, and has full knowledge of other related disciplines, provided direct technical validation engineering support of process and/or equipment upgrades, replacements, and modifications in the laboratory, manufacturing, or manufacturing support environment.
Skills : Knowledge of Regulations, Project Management, Software validation, Root cause analysis, Process improvement
Description :
- Interpreted and applied GLPs and GMPs.
- Applied validation engineering to production.
- Developed solutions to routine technical problems of limited scope.
- Served as laboratory director for high-complexity labs performing molecular diagnostic testing. Prefer someone who has a Florida license and an NY CoQ.
- Performed a variety of clinical laboratory procedures including nucleic acid extraction and quantification, quantitative real-time, and next-generation sequencing under established protocols.
- Performed both manual and automated techniques to accomplish high-volume sample processing.
- Managed multiple validation projects simultaneously, ensuring timely completion and adherence to quality standards.
Experience
2-5 Years
Level
Executive
Education
PhD Pharm Sci
Validation Scientist Resume
Summary : As a Validation Scientist, trained in Aseptic Process Simulation (Media Fills), Airflow Visualization Studies (Smoke Studies), Environmental Characterization/Qualification, well trained in Parenteral Manufacturing and isolators.
Skills : Communication, Critical Thinking
Description :
- Responsible for proposing development and testing improvements to positively impact usability, function, and performance.
- Responsible for demonstrating new product features and functionality to project stakeholders.
- Responsible for meting tight deadlines to satisfy client demands and project timelines.
- Responsible for monitoring and reporting on test results and performance data to identify areas of opportunity for improvement.
- Responsible for developing validation master plans, process flow diagrams, and standard operating procedures.
- Responsible for training and guiding onsite and offshore team members in quality assurance standards, policies, and procedures.
- Responsible for producing and maintaining technical documentation for project reference.
Experience
7-10 Years
Level
Management
Education
BS Chemistry
Validation Scientist Resume
Summary : As a Validation Scientist, prompted and regularly attended to the workplace, transferred, pharmaceutical, medical devices, and biotechnology in manufacturing, inspection, and packaging processes.
Skills : Laboratory Skills, Software Proficiency, Technical Writing, Analytical Skills, Documentation Skills
Description :
- Participated in equipment maintenance, QC/QA, and proficiency testing procedures.
- Provided detailed, accurate, and legible documentation associated with test results, maintenance records, and quality control.
- Troubleshooted assays as needed to assist laboratories both onsite and remote.
- Assisted with the validation of new assays, and completed other laboratory tasks as assigned.
- Served as remote technical supervisor for laboratories; responsible for QA/QC review monthly.
- Adhered and ensured laboratory staff adhered to OSHA, HIPAA, and other safety practices.
- Identified and reported unsafe equipment, conditions, and practices so that they may be corrected before an incident
Experience
7-10 Years
Level
Management
Education
BS Chemistry
Validation Scientist Resume
Headline : As a Validation Scientist, applied knowledge of validation engineering principles and practices outside of my area of expertise to a broad variety of assignments in related fields, and developed departmental budgets or project budgets encompassing multiple disciplines for areas within projects or the entirety of smaller projects.
Skills : Technical Knowledge, Regulatory Compliance, Technical Writing, Data Analysis
Description :
- Responsible for leading risk assessment meetings, offering input on assessments such as system impact, component criticality, data integrity, and other factors.
- Responsible for identifying causes of equipment failures and making suggestions for issue resolution.
- Responsible for explaining highly complex information in terms easily understood by non-technical personnel.
- Responsible for participating in the system design and commissioning phase, interfacing directly with clients to ascertain clear, concise milestones for integration into development timelines.
- Responsible for training and assisting staff in validation techniques, methods, and testing processes.
- Responsible for working with stakeholders and team members on quality assurance efforts for hardware components.
- Responsible for driving corrective actions to accomplish project closure and recurrence control.
Experience
5-7 Years
Level
Executive
Education
BS Chemistry
Validation Scientist Resume
Summary : As a Validation Scientist, supervised, coordinated, and reviewed the work of a small staff of engineers and/or technicians on an ongoing basis as well as on a project basis, employed advanced validation engineering techniques and/or modifications of advanced techniques within the area of validation engineering expertise.
Skills : Analytical Skills, Documentational Skills, Data Analysis, Regulatory Compliance
Description :
- Performed calibration and quality control samples according to the procedure.
- Ensured troubleshooting is performed when calibrators/quality controls fail and properly documented.
- Ensured accuracy and precision of quality control data and patient results.
- Drafted SOPs, laboratory forms, and validation summary reports.
- Trained in analytical method development, qualification, validation, and transfer.
- Followed techniques, HPLC, LCMS, GCMS, ICP-MS, UV/fluorescence spectroscopy, qPCR, and biochemical (enzyme) assays.
- Worked on the application of method validation principles for regulated industries including FDA cGMP; ICH/USP guidelines ANSI/ISO/ASQC; FMEA, Risk Analysis, and Design Controls.
Experience
7-10 Years
Level
Management
Education
BS Chemistry
Validation Scientist Resume
Headline : As a Validation Scientist, completed complex or novel assignments requiring the development of new and/or improved validation engineering techniques and procedures, and developed validation engineering policies and procedures that affect multiple organizational units.
Skills : Attention to detail, Problem Solving, Root Cause Analysis, Team Collaboration, Communication Skills, Documentation Skills
Description :
- Responsible for supporting manufacturing scale-up efforts by providing technical expertise in the area of process validation.
- Responsible for contributing to successful audits by maintaining organized records of all validation activities and results.
- Responsible for mitigating risk during technology transfers by performing thorough assessments of vendor qualifications and capabilities before engagement.
- Responsible for enhancing validation processes by implementing risk-based strategies and utilizing statistical tools.
- Responsible for improving overall efficiency by streamlining data analysis workflows and automating repetitive tasks.
- Responsible for documenting the entire validation process, noting changes or alterations completed.
- Responsible for analyzing pre-release software titles for compliance with User Requirement Specifications (URS), referring any deficits to appropriate personnel.
Experience
5-7 Years
Level
Executive
Education
BS Chemistry
Validation Scientist Resume
Objective : As a Validation Scientist, applied advanced and diverse validation engineering principles to the design and implementation of major system or process modifications and/or capital projects, developed, organized, analyzed, and presented an interpretation of results for operational issues or validation engineering projects of significant scope and complexity.
Skills : Risk Assessment, Continuous Improvement, Process Improvement, Software Validation, Equipment Qualification
Description :
- Provided leadership to Validation Scientists (I&II) by delegating projects, training/mentoring, and tracking project progression.
- Prepared and executed protocols and written reports.
- Reviewed documents from team members.
- Guided junior members on various validation requirements (through team meetings and individual interactions).
- Reviewed and approved master batch records, deviations, and maintenance reports (as qualification is established).
- Attended client meetings as a validation representative.
- Updated assigned Master Validation Plans (MVPs) as per validation policy.
Experience
2-5 Years
Level
Executive
Education
BS Chemistry
Validation Scientist Resume
Headline : The Validation Scientist is a key player in the quality assurance landscape of the pharmaceutical industry, focusing on the validation of processes, equipment, and analytical methods. This role involves the creation of validation documentation, execution of validation tests, and analysis of results to ensure compliance with regulatory standards. A thorough understanding of Good Manufacturing Practices (GMP) and the ability to work collaboratively with cross-functional teams are essential. The Validation Scientist also plays a role in training staff on validation procedures and best practices.
Skills : Critical Thinking, Quality Assurance, Team Collaboration, Root Cause Analysis, Software Validation
Description :
- Responsible for developing robust validation protocols by collaborating with cross-functional teams and adhering to industry guidelines.
- Responsible for facilitating knowledge transfer within the organization through regular presentations, training, and written reports on validation best practices.
- Responsible for optimizing the performance of analytical instruments through periodic calibration and maintenance.
- Responsible for achieving successful outcomes in validation projects by fostering an environment of collaboration, open communication, and continuous learning.
- Responsible for increasing compliance with regulatory requirements through rigorous documentation practices and continuous improvement initiatives.
- Responsible for identifying opportunities for cost savings in the validation process through careful analysis of resource allocation patterns and utilization rates.
- Responsible for reducing process variability by optimizing experimental design and applying advanced statistical techniques.
Experience
5-7 Years
Level
Executive
Education
BS Chemistry
