Downstream Purification

• Act as a validation Subject Matter Expert (SME) providing support to multi-function teams, advise operations on validation matters, and serve as point of contact to present validation programs and strategies to inspectors and auditors.• Experience with equipment/utility/facility qualifications and general commissioning, qualification and validation•Experience with investigations, deviations and CAPA management in a regulated pharmaceutical industry.•Experience and in-depth understanding of validation lifecycle deliverables and documents from equipment design through qualification (starting with URS, to the end of IQ/OQ/PQ).• Execute and/or lead multiple projects that require qualification work arising from change controls, capital projects, and ongoing supplemental validation deliverable per approved validation plans as a point of contact for project stakeholders.• Work collaboratively with peers within the cross-functional teams (ENG, AUTO, MFG, QE, QC) to manage workload to address priorities, meet schedules, maximize productivity, reduce costs and increase efficiency.• Performs assessment of validation work and executes validation work arising from change controls, capital projects, shutdown/changeover activity, and ongoing revalidation programs.• Knowledge of process automation system software (preferably Delta V batch).• Works both independently and in a team environment at all levels of the organization in particular Quality, Engineering Automation and Manufacturing Operations.• Becomes actively involved as required to meet schedules or resolve problems. Erroneous decisions or failure to achieve results may have financial implications or cause delays in schedules.• Identifies and reports any discrepancies from normal practices or procedures to senior management, recommending and implementing corrective actions.• Acts independently (often in line with Validation Manager suggestion) to determine methods and procedures on new assignments.

• Specifically designs & develops validation protocols, provides expertise to associated equipment & automation design / modifications.• Coordinates Equipment & Cleaning Validation Protocols (development & management) for specific equipment areas – including presentation of technical training & support to personnel, with on-floor guidance.• Leads validation innovation project efforts requiring cross-functional & contract resources. • Completes project management tracking of deliverables for metrics & reporting. • Attends FAT (Factory Acceptance Testing) for new equipment systems as validation subject matter expert (SME), supports equipment startup & commissioning efforts, as required.• Provides input & validation expertise to Technology Transfer & project / area support efforts, actively participates in related meetings. • Authors sections of Validation-related reports & project plans, provides technical evaluations of validation requirements for core change controls & associated action plans. • Approves TrackWise-generated workflows (deviations, core change controls) for equipment related changes, reviews automation protocols, & attends related meetings. • Initiates / Reviews / manages updates to procedures & forms. Maintains personal training, goal development, & progress tracking.

• Serve as a delegate to approve cleaning validation protocols, deviation reports, and summary reports in lieu of Validation Management• Generates and executes documentation for Cleaning Validation ensuring compliance with QA and cGMP systems.• Leads validation innovation project efforts requiring cross-functional & contract resources• CFE Trainer that provides training to colleagues for swab qualification and gowning procedures into manufacturing areas.• Authors assessments and justifications for Validation Management and Investigational use.• Collaborates with Manufacturing, Investigations, and Statistics & Technology group for investigational support.• Updates validation related SOPs, as needed.• Create and schedule sample testing with Chemical and Biological labs.• Calculate and set MAC limits for product contact equipment.• Scribe as needed for audits (FDA, EMEA, Astellas, Saudia Arabia, ANVISA, Coporate)

• Author and execute engineering studies and validation protocols.• Updated validation related SOPs, as needed.• Assemble data, documents, write and circulate validation reports for approval• Follow and comply with GMP, GLP and FDA guidance.• Create and schedule sample testing with Chemical and Biological labs• Address deviations through VDRs• Calculate and set MAC limit for product contacting equipment.• Conducted engineering studies to developed new cleaning methods, when needed.• Performed cleaning validation projects which supported the cleanability for different contact materials by challenging the equipment at/above maximum dirty hold time using the best challenge products for both solubility and toxicity.• Performed Clean-in-Place validation including Stationary Solution Tanks.• Performed Clean-out-of-Place validation including Portable Solution Tanks and Solution Miscellaneous Parts (sample thieves, dipticks, gassing wands, agitators, pitchers, filter housings, solution pumps, etc.)• Scribe as needed for audits (Astellas, Saudia Arabia, ANVISA, Coporate, FDA, etc.)• Work with Material Science & Technology to provide CV within a project timeline • Lead project for new Swab Qualification training program with Hyde Engineering and Pfizer management across different business units. Implemented three (3) new SOPs, test method transfer, and creation of training documents.

• Execute cleaning verification and validation studies experiments, and protocols.• Assemble data and documents• Understand and follow SOP's.• Follow and comply with GMP, GLP and FDA guidance.• Create and schedule sample testing with Chemical and Biological labs

• Use the pharmacy’s computer to access prescription information including patient and prescriber data• Correctly calculate dosages, prepare prescription labels, and dispense medications for approval by pharmacists.• Demonstrate accuracy in cashiering, cash handling and credit-card processing, consistently balancing cash drawer.• Contacted patients for supply and status update under the supervision of the pharmacist.• Cleaned, maintained and properly sterilized equipment used.• Assisted pharmacists in managing the pharmacy – Maintained database of the drugs used, and ordered supplies accordingly.• Follow proper procedures for ordering, checking-in, and stocking merchandise, both prescription and OTC.• Call physician offices for refill requests and resolve Third Party discrepancies.• Assist with pharmacy paperwork, including sorting and storing written prescription forms, and reconciling Third Party charge and payments.

• Operated a 30 L bioreactor to learn key microbiological techniques and processes used by biomanufacturing industries as well as SIP and CIP. • Gained experience in bioreactor operation and design, scale-up, fermentation process, cell growth, optimization, media sterilization and preparation.• Operated a 2 Liter fermenter to express recombinant protein Pfu CelB in Escherichia coli• Expressed recombinant antibody fragment scFv13R4 in Escherichia coli using Fed-batch strategies. • Cloned egfp gene into pET-41a(+) plasmid • Assessed protein recovery by using affinity chromatography, Bradford Assay, and SDS PAGE.• Followed and revised SOP for a 100,000 class clean room• Evaluated CIP testing through Bioburden, Total Organic Carbon, and Residual testing

Maintain records of patient health information