Cleaning Validation Scientist Iii - Henrico, United States - FAREVA - Richmond

Description

Fareva is currently seeking an experienced
Cleaning Validation Scientist III to join our team in
Richmond, VA.

JOB SUMMARY:


JOB RESPONSIBILITIES:


Support of Cleaning Validation related activities includes:

• Writing and reviewing cleaning and sanitization procedure instructions for operations
• Study execution: protocol/report authoring and review, training, execution of cleaning validation activities and sample collection
• Execution of cleaning validation/verification activities from process development through process campaigns
• Ensuring compliance with regulatory standards and internal validation master plans associated with Cleaning Validation
• Writing, reviewing and executing related cleaning validation studies such as extraction and recovery studies
• Writing, reviewing, and executing cleaning development protocols including lab scale coupon studies, full scale spray coverage testing, and fullscale cleaning recipe and procedure development
• Creation of final reports summarizing development data and risk assessments for determination of cleaning matrix and critical cleaning parameters for validation
• Supporting investigation of deviations encountered during the execution of validations and/or continuous monitoring/verification activities and provide documentation to support the findings of the investigation
• Performing risk assessments for determination of most critical cleaning conditions and acceptance criteria
• Responsible for accurately summarizing results and conclusions when writing final reports.
• Ensuring final reports and study data are reviewed and approved in a timely manner
• Sampling for cleaning studies including collection of surface swab sampling and the submission of samples to QC lab for testing
• Coordinating and scheduling cleaning development, validation and, continuous monitoring/verification activities with appropriate departments
• Supporting developmental projects in relation to modifications or implementation of new cleaning equipment/processes
• Writing and providing training on SOPs relevant to cleaning validation procedures
• Training of personnel on surface swab sampling
• Reviewing technical and quality system documents such as SOPs, Change Control, Deviation Reports, and Batch Production Records, as they relate to cleaning validation and regulatory compliance issues
• Training of cleaning personnel in Operations as required on new cleaning requirements or revisions to existing proceduresProvide SME support for external/internal regulatory compliance audits
• Providing support as Cleaning Validation SME during external/internal driven compliance audits

Change Management:

• Monitoring of the General Technical Report database for new Cleaning Validation support requiring Change Controls
• Initiation of Change Controls as needed to modify cleaning validation support documents
• Revision of Production Batch Records, Product Instruction Documents, Cleaning Validation support documents, and/or other relevant documentation
• Providing SME knowledge of Cleaning Validation standards for database management and Change Control processing
• Keeping track of all commitments and apprising Cleaning Validation Supervisor of project status

Troubleshooting and Process Improvement:

• Participation as site primary Cleaning SME to support continuous improvement of current processes and development of new technology
• Developing and implementing methods to systematically evaluate Cleaning Validation process problems
• Troubleshooting technical problems related to equipment cleaning and implementing short

- and long-term solutions to prevent recurrence.

• Developing and implementing methods to systematically evaluate Cleaning Validation process problems
• Working directly with crossfunctional groups to resolve system problems to improve quality and efficiency
• Performing or overseeing special studies on new process/projects (e.g new materials of construction)

Administrative:

• Inventory and ordering Cleaning Validations supplies as needed.
• Maintaining the Cleaning Validation area of the Laboratory that is dedicated to Cleaning Validation.
• Tracking the expiration of reagents used for Cleaning Validation sampling
• Maintenance of databases supporting the Cleaning Validation program including equipment, product, marker selection, matrices, and all other databases designed to support the program

Quality Compliance/Safety

• Promoting cGMP compliance within the workplace by following site cGMP procedures. Incorporate cGMP and regulatory compliance into all assigned projects and procedures
• Following site safety and compliance guidelines. Work in a safe manner in all cGMP areas of the facility

EDUCATION:

Minimum of a Bachelor's degree in a scientific discipline (e.g. Microbiology, Biology, or Chemistry); preferred at least four (4) years of pharmaceutical or relevant experience


TECHNICAL SKILLS:

• Keeps abreast of current developments and trend