Cleaning Validation Scientist III - Three Chopt, United States - FAREVA RICHMOND, INC

Description

Cleaning Validation Engineer III

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

Position Summary

The Cleaning Validation Scientist III is responsible for lifecycle management and execution of all Cleaning Validation activities in support of commercial manufacturing. Responsibilities are delegated by senior management or can be self-directed based on project or production needs. Prepares necessary cleaning validation process and procedural documentation as site subject matter expert (SME). Coordinates all cleaning validation activities with impacted departments and personnel. Follows and maintains cleaning validation area processes and procedures. Knowledgeable in cleaning validation concepts, practices, and procedures. Leads and instructs the work of others to support cleaning validation deliverables.

Position Responsibilities

● Cleaning Validation Lifecycle Management

○ 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 full-scale 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 procedures. Provide SME support for external/internal regulatory compliance audits

■ Providing SME support for external/internal driven compliance audits

● Change Management

○ Maintenance of databases supporting the Cleaning Validation program including equipment, product, marker selection, matrices, and all other databases designed to support the program

○ 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 Cleaning SME to support continuous improvement of current processes and development of new technology

○ Working with the Cleaning Validation Supervisor to troubleshoot and technical problems and identifying short- and long-term solutions

○ Developing and implementing methods to systematically evaluate Cleaning Validation process problems through analysis of data from failures, and make recommendations to prevent recurrences and/or trends

○ Working closely with cross-functional groups to resolve system problems to optimize output, minimize contamination, and minimize cost

○ Performing or overseeing special studies on new process/projects (e.g new materials of construction)

● 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 and Experience Requirements

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

Technical Skills Requirements

● Has strong knowledge of subject matter in Cleaning Validation or has broad technical knowledge to apply to this area

● Keeps abreast of current developments and trends in areas of expertise. Assimilate and apply new job-related information that may vary in complexity within a reasonable period of time

● Ability to write clear and concise technical reports, business evaluations, process descriptions, and standard operating procedures, with some input from supervisor. Technical writing experience preferred

● Effective active listening skills

● Fosters open communication with individuals at all levels of the organization

● Articulates important issues and solutions to both technical and non-technical peers and to department management

● Assimilates new knowledge skills, and job-related information that may vary in complexity, and applies them to work assignments in a timely manner

Physical Positions Requirements

● Must be able to walk carrying equipment (cart and sampling instruments) through Operations, climb stairs, and lift at least 25 lbs