An excellent company to work for.

My Father could not reside in an assisted living facility. So, I stayed at home to take care of him myself. The situation has been resolved.

• Validation of UV/Vis Spectrophotometers.• Execution and summary of a Vacuum Infiltration System.• IQ of a 240vac heat exchanger.• Various items of technical writing for VMPs (Validation Master Plans).• Experience with Master-Control Quality Excellence (a QMS).• Batch record review for approval of PQs (Process Qualifications)• Commissioned (validating) Quality Management System software against ISO 9001 standards.• Performed Kaye Valprobe re-qualification of equipment loads in an autoclave. • Investigated deviations, non-conformance reports (NCRs), and out of specification (OOS), investigations, insuring that CAPA reports were written and correctly instituted prior to release of affected batches. Performed root cause analysis (RCA), documenting every step of the inquiries

• Authored and Trained others on new/revised Standard Operating Procedures of direct and indirect-impact equipment,• Equipment qualification of a United Pharmatek Tube-Filler, two processing tanks with homogenizers, a lab mixer, a hot-box oven for drums, temperature control units (refrigerators and freezers) and a QC glass washer.• Authored User Risk Assessments (URSs) for said equipment.• Authored, executed, summarized, and trained staff on the IOQs (IQ/OQs) of said equipment.• Trained to become a proficient user of using KNEAT software to upload, route, edit, and approve protocols.

• As a Senior, the majority of my time was dedicated to reviewing and approving the work of other Engineers.• Executed and summarized SIP and Shelf-Mapping of Serile lyophilizers.• Assisted in executing and summarizing vial washers, depyrogenation tunnel, and vial filler.• Wrote qualification protocol for an Excel spreadsheet.• Authored User Risk Assessments (URSs) for mobile, stainless, aseptic compounding and product-chill tanks, including utilities and control interfaces.• Executed Engineering studies and test runs of 20mL glass, in a rotary vial washer, and on a Bosch Vial Filling Machine (filler). • Technical review of machinability and PQ protocols for vial washer, depyrogenation tunnel, vial filler, and other aseptic manufacturing equipment. • Determined the sampling levels & AQL via ISO 2859 (ANSI/ASQ Standard z1.4-2003).• Authored, executed, and summarized a lyophilizer shelf-mapping study, comparing results from aluminum pucks with and without thermal paste, as well as distance from various shelf edges and refrigerant supply piping.

• A 6-week stint to author, execute, and summarize a PQ (process validation) for filling and capping 3mm and 20mm product components on a Bosch Filler (ISO Class 1) and Bosch Capping Machine (capper) in an ISO 5 environment.• Aiding in executing process validation of the lyophilization of vials.

• Contracted to create a certification program for Packaging Operators. Included my creation of study guides, comprehensive exams, as well as a training curriculum, overview SOP and other documentation.• Batch record review for approval of PQs.• Managed contract-customer projects, as described above under ‘Manufacturing Process Engineer.’• Worked with an outside contractor to develop swabbing and testing methods for the cleaning of equipment.• Spearheaded technology transfers of new products to Manufacturing.• Responsible for selection of suitable equipment to meet the processing and packaging requirements of device products.

• Brought in as an equipment expert, I was put onto a team validating HVAC units used to condition and filter air to Production laboratories, clean rooms, and product warehouses, including the writing and closeout of several critical variances. The OQs and PQs included extensive temperature and humidity mapping of the climate-controlled areas, using calibrated MadgeTech thermal data loggers. • Wrote a comprehensive systematic SOP, for the use of the Amphenol Kaye Validator, as well as authoring the IQ/OQ of one of the units. Assisted in annual qualification runs involving empty chambers, a liquid load, and various equipment loads.• Authored, executed, and summarized an IOQ of a cold room, and several upright refrigeration units, using both data loggers and a Kaye Validator. • Executed and summarized the IOQs for Climet viable, and Climet non-viable particle counters.• Part of a multi-discipline team to solve process design and product performance issues relating to the polymers used for vial closures, and their relation to steam-related deformation, Failure Mode and Effects Analysis (FMEA) included.• Managed internal projects, including: Kick-off meetings; Developing project plans and Gantt charts; Identifying possible conflicts and constraints; Coordination of resources; Tracking progress and budgets; Submitting capital requests and justifications; Removing roadblocks; Writing ECOs as well as interim and contingency plans; Motivating resources as necessary.• Identified equipment requiring upgrade/replacement, for the purposes of compliance, safety, or efficiency, relieving both existing and expected bottle-necks. • Initiated, modified, and enhanced SOPs and batch records, assuring process compliance to NDAs/ANDAs, FDA, EU, DEA, ISO, OSHA, environmental regulations, and the customer’s needs and concerns.• Prepared written reports, as the chief investigator for Deviation and Non-Conformance investigations.

• Aided in oversight and facilitation of initial phases of the project life-cycle for an abbreviated new drug application (ANDA). • Strong collaboration and communication skills. • Responsible to define project plans and implement according to target deliverables and schedule.• Acting Quality Editor, reviewing submission sections from other individuals for comprehension, scientific authenticity, and accuracy.• Lent my expertise to the Validation department for the qualifications and investigations of cleaning validation.• Wrote user requirements specification (URS) development based on process flow discussions with users (the SMEs).• Wrote functional requirements specifications (FRSs) development from existing documents and from input from SMEs• Trace matrix development and analysis to determine quality gaps.

• Performed as Project Manager and Manufacturing Engineer, creating user requirement specifications (URSs), to purchase and then qualify equipment for various sections of a sterile medical device process.• Managed four of the five project phase requirements: Initiation, Planning, Execution, and Monitoring & Control.• Developed overall process, using six sigma methods / design methods, for the product flow through several manufacturing machines. • Performed qualification of ISO 4 (Class 10) cleanrooms, documenting and summarizing particle counts, flow rates, and laminarity of airflow.• Wrote, executed, and summarized IOQs and PQs for the equipment, which often included Allen-Bradley PLCs.• Supervised three days of FAT at the manufacturing plant of a depyrogenation tunnel, reviewing data from Kaye Validators and various magnehelic chart recorders to ensure a robust process.• Authored process validations for two fill lines involving the aseptic processes of Gruenberg ovens and Cozzoli vial fillers, all with Allen-Bradley PLCs. • Performed Failure Mode and Effects Analysis (FMEA) on equipment and processes, identifying possible failure modes, and determining detection methods. • Assisted in the execution of OQ protocols for VHP-decontamination of, and environmental monitoring (viable and non-viable) of class 100 barrier isolators.• Performed FAT of an isolator-enclosed Shibuya aseptic vial and ampoule filler, suggesting modifications to minimize glass breakage, and to better adjust for the height discrepancies at the seal placement station.

• Commissioned (validating) Quality Management System software against ISO 9001 standards.• Performed as the site's Technical Writer accountable for writing SOPs for generic injectable and oral dose processes and equipment, as well as ANDA submissions, component specifications, and product specifications. • Acted as lead-investigator for deviations, non-conformance reports (NCRs), and out of specification (OOS), investigations, insuring that CAPA reports were written and correctly instituted prior to release of affected batches. Performed root cause analysis (RCA), documenting every step of the inquiries. • As part of a Validation deviation /CAPA, performed feasibility studies for sterilization/depyrogenation through a vial tunnel. • Worked with Maintenance and outside contractors to qualify electrical grid, filtered compressed air, and compressed nitrogen piped systems.• QA review and approval of deviations, NCRs, and CAPAs written by the Production Department, including tracking of change control to ensure a timely and correct closeout. • Maintained database of quarantined product from deviations / CAPAs, giving QA Release only when all additional documentation (such as updated SOPs) and training had been performed.

Quality Assurance (Sterile Injectables and Solid Oral Doses):• Hired initially as a Document Specialist to review completed batch records for errors; revise master batch records and SOPs (via proper change control) relating to production activities, to maintain FDA compliance; performed line inspections; line-clearances; and in-house audits of all documentation.• Collected and reviewed batch related data from Analytical Chemistry and Microbiology departments. Performed QA Batch Release.• Determined relative standard deviations (RSDs) of stability samples and performed trending, aiding QC Chemistry in writing summary reports.• Worked with the Director of Quality Assurance on authoring the response to a 483, as well as the monthly remediation status reports for the FDA (per consent decree).• Worked on continuous improvement using some six-sigma methodology.• Provided technical expertise on multidisciplinary projects, tasks, and technology transfers, utilizing an objective scientific approach.• The technical expert for Manufacturing on all processes, and projects. Utilized knowledge to trouble-shoot problems with formulations, tanks, RO and WFI systems, in-house nitrogen, product variations in pH, osmolarity, viscosity, filterability, etc.Validation Engineer• Solid dosage equipment: powder, tablet, and bolus fillers; tablet-presses, dry-bed mixers, and drying oven. Aseptic equipment: vial filler; stopper washers; glass washer; and clean-room airflow mapping. • Assisted manufacturer of a new non-viable aseptic-suit-wide particle counter system, with performing qualifications and summarizing the manual into an SOP. Provided weekly download and analysis of the particle counter, performing graphing and trending to determine anomalies. • Authored, executed, and summarized cleaning validation of the equipment above, as well as for compounding equipment.• Reviewed and approved executed validation protocols performed by other Validation Engineers.