Manager Engineering

Kari H. Moore

**** ****** ***** *****, ******, VA 23093

540-***-**** ****.*.*****@*****.***

OBJECTIVE

Seeking a challenging and rewarding position where I can apply my knowledge and experience in cGMP manufacturing, validation, product development, and/or engineering.

SUMMARY OF EXPERIENCE

11 years of pharmaceutical experience: 7 years in contract manufacturing and 4 years in dedicated process manufacturing.

Qualification/Validation Experience:

oDepyrogenation

oCleaning (Parts Washers and CIP)

oAutoclave Sterilization (components and terminal sterilization)

oVial Washers

oProcess Development and Validation

oUtilities (WFI, HVAC, Process Air)

oControlled Temperature Storage Units

oIsolator Decontamination

oVacuum Chamber Heat Sealers

oClean Steam Testing

Documentation Experience:

oSOPs

oDeviation Investigation Reports

oCustomer Complaints

oBatch Records

oAtypical Investigation Reports

oCAPAs

oChange Control

oFAT, IOQ, PQ Protocols

oRisk Assessments

oMaterial Specifications and Release

oValidation Master Plans

oGap Assessments

oAPRs

Continuous Improvement Training:

oSix Sigma Yellow Belt and Green Belt

oToyota KATA

Auditing Experience:

oPerform internal audits of quality, production, and facility systems

oProvide technical support for on-site regulatory and client audits

PROFESSIONAL EXPERIENCE

Afton Scientific, Charlottesville, VA

Associate Manager, Quality Assurance

Apr. 2015 - Present

Provide guidance, review, and approval of pre- and post-execution qualifications (FAT, IOQ, PQ) of new and existing equipment/systems for both an existing contract aseptic processing facility and as part of commissioning for a new manufacturing facility.

Review and approve change control documents for equipment and manufacturing processes

Author, review, and approve SOPs and Batch Records required for commercial and development production batches.

Investigate and review deviation reports and complaints for root cause and corrective actions.

Review executed batch records for release of finished product.

Complete routine operator reviews for aseptic practices and behavior.

Participate in regulatory, client, and internal audits.

Assist in turnover of equipment and processes from Engineering to Production to ensure a smooth transfer of knowledge and best practices for classified areas are maintained.

Participate in Pharma & Biopharma Outsourcing Association (PBOA) as a Quality Technical Group member to provide input from a small contract manufacturer perspective on new regulations. Also, regularly attend PDA and other industry related conferences.

Lead site serialization project to meet DSCSA requirements for both serialization and aggregation of finished product. Acted as a liaison between engineering, system vendor, and client to ensure specifications for all existing clients are met while maintaining system flexibility for future projects.

Merck & Co., Elkton, VA

Specialist, Engineering – Biologics Technical Operations Oct. 2011 – Apr. 2015

Provide floor and on-call support for the cleaning, build, and sterilization of equipment used in downstream closed system processing for fermentation, purification, and dispensing operations.

Lead continuous improvement projects to reduce area cycle times and improve ergonomics.

Participate in Toyota Kata daily as a learner and coach. Participated in Value Stream Mapping for area operations.

Completed Six Sigma Green belt and Yellow belt training.

Coordinate the qualification and implementation of equipment and manufacturing process improvements with all required on-site groups (i.e. Operations, Maintenance, Automation, Quality, Validation, Technical Operations) and outside vendors.

Ensure all annual assessments of area equipment and utilities are executed as required

Create, review, and approve validation protocols for equipment and utilities including IQ, OQ, and PQs.

Initiate and ensure timely completion of change controls for the implementation of area improvements.

Investigate and document area quality notifications and deviations. Determine and ensure completion of corrective and preventative actions including determination of CAPA effectiveness following completion.

Create and revise Standard Operating Procedures and Batch Records for equipment and manufacturing operations.

Interact with regulatory agencies during site audits.

Prepare regulatory filling documents and annual report sections for area operation for submission.

Afton Scientific, Charlottesville, VA

Manager, Technical Operations April 2011 – Oct. 2011

Continue all responsibilities of Manager, Pharmaceutical Engineering (as described below).

Oversee material planning and inventory control management for production processing and development studies.

Oversee documentation management processes including the development, approval, and maintenance of control documents and specifications.

Afton Scientific, Charlottesville, VA

Manager, Pharmaceutical Engineering Aug. 2009 – April 2011

Oversee and manage the implementation of new product manufacturing processes and continuous improvement projects of existing processes.

Create, manage, and coordinate the execution of development plans to determine process flow and equipment requirements for manufacturing processes of new products.

Create, execute, and review qualification protocols (FAT, IOQ, PQ) of new equipment and Process Validation protocols for new manufacturing processes as determined by client requirements.

Communicate with clients on validation protocols and reports.

Partner with Production to determine potential improvements of equipment and manufacturing processes.

Manage the execution of re-qualifications of existing equipment and utilities.

Author and review Standard Operating Procedures for operation and maintenance of new equipment.

Investigate deviations and determine appropriate corrective and preventative actions.

Conduct risk assessments.

Perform internal audits.

Afton Scientific, Charlottesville, VA

Manager, Pharmaceutical Production Sept. 2007 – Aug. 2009

Schedule and coordinate production floor activities and operator duties.

Review documentation of production floor activities including daily batch record review.

Coordinate training of operators.

Perform internal audits and respond to production/operation audits.

Coordinate equipment maintenance with facilities and engineering.

Assist in validation and engineering projects.

Execute Corrective and Preventative Action projects.

Complete manufacturing deviation investigations.

Create, revise, and review Standard Operating Procedures and batch records.

Afton Scientific, Charlottesville, VA

Manufacturing Engineer I July 2006 – Sept. 2007

Evaluate, select, and coordinate the procurement and movement of materials through the production process.

Create, review and manage incoming material specifications.

Interact with clients for both new projects and finished product shipment regarding material requirements.

Review and modify production instructions and Standard Operating Procedures.

Assist in the design of engineering and validation protocols.

EDUCATION

James Madison University – Harrisonbug, VA

Bachelors of Science, Integrated Science and Technology – December 2005

Concentration: Engineering/ Manufacturing

Computing Experience

Microsoft PowerPoint, Microsoft Visio, Html, ProModel, JMP-IN, Microsoft Word, Microsoft Access, ASP, WsFTP, CES Selector 4.0, Microsoft Excel, Visual Basic, TurboCAD, LabView, SAP, Midas, Trackwise, Manufacturing Integration and Intelligence (Mii), Powersteering, Tracelink

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