Christopher Mcpherson Email & Phone Number

Waltham, Ma, Us

Waltham, Ma, Us

Facilities, Equipment and Utility Validation for a new facility startup (Thermo Fisher Plainville MA VVS facility).

Quality Assurance Validation (QAV), Cleaning Validation subject matter expert (SME)Computer Systems Validation Business Quality Representative (BQR)Cleaning validation program owner for Framingham Biologics responsible for maintaining cleaning validation program documents, assessing change controls for validation impact and presenting the cleaning program during auditsRemediated legacy cleaning validation programs using risk-based approachesImplemented cleaning cycle development and validation strategies for multi-product manufacturing including vaccine productionDeveloped and implemented Clean In Place (CIP) validation strategies for upstream and downstream manufacturing equipmentReviewer / Approver of Engineering Lifecycle and Qualification documentation associated with critical process equipment and utilitiesReviewer / Approver of computer systems validation Lifecycle and Qualification documentation associated with critical computer systems

Cleaning validation subject matter expert responsible for all aspects of the cleaning validation program Developed and implemented Clean In Place (CIP), Clean Out of Place (COP) multiproduct validation strategiesImplemented the site Total Organic Carbon (TOC) recovery programValidation lead for extensive site shutdown, responsible for the coordination of validation activities and all validation deliverablesReviewed and executed qualification documents associated with direct impact process equipment and utilities (IQ, OQ, CIP PQ and SIP PQ)Cleaning validation point of contact for audits and inspections

Thousand Oaks, Ca, Us

Cleaning validation subject matter expert responsible for the multi-product cleaning validation program Developed and implemented Clean In Place (CIP) multiproduct validation strategiesCoordinated and implemented the site cleaning characterization programDeveloped cleaning program acceptance criterion and sampling strategiesOrganized the site Total Organic Carbon (TOC) recovery study programProvided utility re-qualification strategiesProvided technical support for CIP continuous monitoring and maintenanceLead the commissioning and qualification effort for manufacturing equipment as part of a large build-outDeveloped site qualification and sterilization philosophiesReviewed and executed qualification documents associated with critical process equipment and utilities (IQ, OQ, CIP PQ and SIP PQ)Evaluated changes for validation impact to critical process equipment and utilitiesOverall quality system program experience including risk analysis, nonconformance, corrective and preventative action, metrics and change controlParticipated directly in regulatory agency inspections

Downingtown, Pennsylvania, Us

Developed and executed IQ, OQ and CIP/SIP PQ documents for client startup and expansion projectAnalyzed specifications and confirmed critical attributes of facilities, utilities and manufacturing/laboratory equipment relating to product and process qualityCompleted IQ, OQ and PQ of a 2000L cell culture train and a purification process suite including chromatography skids and columnsSuccessfully completed SIP and CIP validation of a 2000L cell culture train including transfer lines, bioreactors, UF/DF, filtration skids and centrifuge

Provided support for the start-up, validation and maintenance of equipment, processes and facilitiesExecuted temperature mapping of warehouses, refrigerators and freezersPerformed CIP and SIP PQ validation on 1250L bioreactor trainAuthored and executed validation documents for small-scale cell culture operationMaintained mammalian cell culture in cGMP environmentFacilitated bioreactor turn around operations and maintenance, media/buffer formulation and purification operationsParticipated in the shakedown and startup of a fermentation suite including execution of simulations and testing to support qualification and productionGenerated, reviewed, approved manufacturing deviations, procedures and batch records