Robin Emrick Email & Phone Number

Bear, Delaware, Us

Providing experienced validation support and guidance to FDA-regulated industries to achieve and maintain compliance, including: 2022-23: Boston, MA: Wrote client’s first Cleaning Validation Policy to define a robust cleaning strategy; revised CVMP to a risk-based approach; provided structure for client’s first programs in new product introduction, equipment characterization and visual inspection, and sampling techniques for cleaned equipment; tailored and delivered hands-on training in sample collection.2021: Frederick & Boulder, CO: Created/revised documentation to restructure Cleaning Validation program while serving as Cleaning Optimization Lead at a biologics CMO specialized in oligonucleotide production. Led team on cleaning assessments, worst case soil ranking, swabbing techniques, and MACO calculations. 2020: Rocky Mount, NC: responsible for qualification for three Getinge Parts Washers and supported Optima filling line qualifications during major capital expansion project.2018-2019: Augusta, GA: designed and implemented a manual cleaning validation program for medical device combination product equipment for which there had never been validated cleaning. Prepared and shared site-wide training, tailored per team functions, to ensure adoption and maintenance of first-time validated cleaning program. These included performance of visual inspection, aseptic technique, swab collection and handling, worst case sample location identification, cleaning method development and execution checklists.2016-2018: Elkton, MD: vascular access medical device technology transfer and DHF remediation sustaining projects: V&V, IFU, Clinical Flow, temperature mapping, IQOQ2016: Kintnersville, PA: authored Quality Manual and calibration technical SOPsApplying for WBENC certification.

Hatboro, Pennsylvania, Us

Project work included clients in: - Rockville, MD: qualified Xcellerex portable mixing tanks and Lyon Tech. egg incubators. - Minneapolis, MN: designed cleaning validation program for medical devices while under Consent Decree. - Lancaster, PA: finalized cleaning validations [Tablet Compression Team] under Consent Decree. - Durham, NC: qualified fully-automated liquid filling line for serological (IVD) medical device.

Rahway, New Jersey, Us

Technical Operations - Validation group supporting MMR (Measles, Mumps, Rubella), Black Widow Spider Antivenin and Culture Media departments via CIP validations and deviation management investigations. Experience with supporting Vaqta, Pedvax and distributed Sterile Supply CIP/SIP validations. Responsible for periodic CTU qualifications.Selected Highlights:• Wrote position papers for two departments with data analysis to justify change of dirty hold times, avoiding unnecessary deviation investigations and saving ~$120,000 per year• Wrote position paper to justify matrixing all 2,000L tanks in Culture Media department, saving $80,000 per year in unnecessary annual cleaning validation studies- Wrote and executed initial and annual cleaning validations for fully-automated CIPs and parts washers, such as: 2,000 liter media process tanks, Hamo KG tank washer (designed for 50L – 250L portable process tanks), Hamo T420 and Hamo T21 parts/glassware washers, Branson Ultrasonic washer- Wrote and executed annual cleaning validations for semi-automated and manual COPs, such as: 16L Unipro tanks (custom-made, jacketed tanks on portable skids), Dill UV Irradiator Model UV3E, Stopper washers and delicate instruments, Production-scale purification chromatography columns- Wrote and executed annual thermal validations for manufacturing skids [sterilize in place: SIP] and controlled temperature units (CTUs) such as incubators and autoclaves [sterilize out of place: SOP]- Captained co-rec volleyball team for seven seasons (KMP)

Somerset, Nj, Us

Selected Highlights:• Cleaning validation at Catalent RLR Commercial Packaging was concluded on time and 65% under budget; it was the first such cleaning effort to address brushes as cross contamination concern- Gap analysis and re-design of Commercial cleaning validation program - Cross-contamination risk assessment codified as basis of Cleaning Validation Master Plan- Design and implementation of baseline environmental monitoring program (62+ Commercial packaging suites)- Evaluation and design of monitoring program for compressed air systems- Process validation of fully- and semi-automated bottling, blistering, pouching and carding lines- Packaging equipment validation document composition and execution - URS, FAT, SAT, IQ, OQ, traceability matrixing- Familiar with equipment from Bosch, Capsugel, DT Kalish Swiftpak, Ilapak, Klöckner, Micron Pharmaworks, Multivac, Uhlmann, Zed, and others- Temperature mapping and data presentation - refrigerated and ambient conditions- Participant in internal auditor training program- Write and review SOPs

Dublin, Oh, Us

Selected Highlights:• Conceptualized, refined and presented (Institute of Validation Technology conferences in Brussels and Philadelphia) a novel cleaning risk-assessment program which was adopted at three Cardinal Health contract packaging sites. Cleaning costs were minimized without compromising product safety through codification & control of site-specific, cross-contamination risks. Decisions were documented in the Material Request and Approval Program (MRAP)- Packaging equipment validation document composition and execution - URS, FAT, SAT, IQ, OQ, traceability matrixing- Environmental monitoring (12+ Clinical packaging suites) & trend analysis- Potable water monitoring & trend analysis- Metrology (calibrations & preventive maintenance program administrator)- Temperature mapping - refrigerated and ambient conditions- Cleaning validation- Write/review SOPs

Dublin, Oh, Us

Selected Highlights:• Self-selected to design and implement Safety Training Curriculum to meet OSHA standards• Self-selected to design and implement Aseptic Technique Awareness Training• Recognized deficits in Cardinal Health Clinical cleaning validation program and self-selected to conduct studies to optimize detergent selection and process parameters for CIP and COP approaches: concurrently addressed clean hold time and dirty hold time gaps- Cleaning validation protocol writing and execution- Packaging equipment validation execution: IQ, OQ- Environmental and potable water monitoring & trend analysis- Design and implement Safety Training Curriculum and with appropriate support materials

Edison, New Jersey, Us

Curriculum Development for:-- 6th & 7th grade, General Science-- 8th grade, French 1-- 9th & 10th grade, Biology & ChemistryExtracurricular:-- Coached girls' high school soccer-- Coached girls' middle school volleyball-- Computer Club advisor-- Mentored two new teachers

Washington, District Of Columbia, Us

Republic of Guinea, 1991-93:- Teacher- PCV Advisory Counsel representative from the Basse Côte region- Liason for the Comité de Décentralization Rurale [CRD] in the American Ambassador's small business enterprise program- Vaccination coordinator for the Organizzazione di Cooperazione Internazionale [CESTAS]- Assisted fellow volunteers with Small Business Enterprise Program initiativesIslamic Republic of Mauritania, 1990-91:-- Water and Sanitation program -- Coordinated village efforts in fresh-water well and latrine construction - materials estimation/procurement, budgeting, 'sweat-equity labor commitments', cross-cultural educationFSI Language proficiency scores: 1.5 (Hassaniya Arabic) and 4.1 (French). These are ranked on a scale where 0 = no exposure and 5 = native speaker.

Bachelor'S Degree, Biochemistry

M.S. Candidate (30/30 Credits), Microbiology