JENNIFER ROSNER
***** ******** **. *********, ** 44122 Mobile: 908-***-**** / Home: 216-***-**** acwn3i@r.postjobfree.com
SUMMARY
Primary focus has been project related within Quality Systems and the Validation / Qualification testing in Pharmaceutical and Medical Device Pilot Plant and Aseptic manufacturing and operations environments (including related computer systems and automation of noted systems). On the floor experience in quality operations, including Corrective Actions Preventative Actions (CAPAs), change management, event/deviation/non-conformance investigations, risk assessments, gap analyses, root cause analysis, spare parts management, preventative maintenance (PM) tracking, calibration system management and tracking, documentation and records, training, and SOP/Validation Protocol/Report writing and reviewing. Solid background in cGMPs and interfacing with vendors / outside manufacturers, with a heavy focus on working in a safety environment (PSM – process safety management). Working knowledge of FMEAs, product and process quality activities, and process flow diagrams. Strengths include: technical writing, problem solving, managing workflow and deliverables of contractors effectively, juggling ever changing priorities, ability to deliver high quality results / products to clients on time and within budget, and interfacing effectively and successfully with various groups from all levels of an organization, representing diverse needs, backgrounds, and personalities. Excellent organizational, communication, and clear, concise writing skills.
EXPERIENCE
1/2016 - Present
CQV Lead Engineer, NNE Pharmaplan (Xellia), Bedford OH
Lead Validation engineer for a team of CQV contractors bringing an aseptic pharmaceutical mfg. site back up to production
Assigning and delegating workloads for employees and contractors
Reviewing and writing qualification protocols
Managing a global team
Providing metrics and reports to upper management
Documentation Control Manager for team of Documentation Specialists directing their workload and activities
Routing documents for reviews and approvals
Quality Engineer for project documentation and activities required for turnover to customer
6/2015 – 1/2016
Test Manager, QualiTest, Highland Heights OH
Managing large group of contractors on site at medical device client
Developing management plans and KPIs for projects
Responsible for scheduling, training and mentoring direct reports, performance reviews, maintaining employee-client relationships, and conducting interviews
Working as a verification tester, executing test scripts, closing out defects
Using Applications Lifecycle Management (ALM) software, becoming familiar with CT/PET technology
8/2014 – 4/2015
Sr. Validation Specialist, AMRESCO, Solon OH
Responsible for bringing a filling and packaging line, which included 13 pieces of equipment, into compliance by leading cross-functional team (operations, engineering, product development, validation, quality, safety) in validation project. Deliverables included all validation documentation (protocols and reports) in less than 7 months.
Participated in FMEAs and aided in developing CQAs/CPPs and Process Flow Diagrams
Generated risk assessments and evaluations of validated systems within change management system
Wrote, executed, reviewed, and closed out Process / Product Qualifications/Validations of medical device products
Wrote and updated work instructions and standard operating procedures (SOPs) for various equipment and processes on site
Worked to troubleshoot problems and suggest improvements to processes and current equipment configurations
Managed and lead cross functional teams to complete qualification/validation projects and meet compliance deadlines
Helped develop and mentor colleagues in quality and validation practices, processes, and theories
Wrote, executed, reviewed, and closed out qualification/validation protocols (Installation Qualifications (IQ), Operational Qualifications (OQ), Performance Qualifications (PQ)) for filling and packaging equipment
1/2014 – 5/2014
Sr. Process Engineer, Kelly Services (through Ben Venue Labs), Bedford OH
Developed and implemented site procedures (SOPs, WIs) for various systems and processes, generated risk / impact analyses
Maintained qualified status of validated / GMP systems by writing, reviewing, and closing out CAPAs, Change Controls, Events, Deviations, and Investigations associated with those systems.
Developed and implemented plans for the improvement of the re-qualification process and continued monitoring of controlled temperature storage units
Generated Periodic Reviews (PRs) for various systems including Clean Steam, Water For Injection (WFI), & Nitrogen
Developed, executed, reviewed, and closed out qualification protocols for steam sterilizer (autoclave) system and controlled temperature storage units (CTS / TCUs)
5/2012 – 12/2013
Principal Validation Engineer, Ben Venue Labs, Bedford OH
Participated in the quality oversight of aseptic manufacturing facility and utility systems, generated risk analyses
Managed qualification/validation projects and resources
Initiated, implemented, closed out CAPAs, change controls, root cause analyses, deviations, and investigations
Developed Water for Injection (WFI) and Clean Steam Qualification/Re-Qualification/Periodic Review SOP
Developed, executed, and closed out project related protocols to address various facility changes (e.g. eqpt. qualification, air handler qualification, BAS monitoring systems, WFI, Clean Steam, & N2 systems)
Generated Periodic Reviews for various systems including HVAC, Clean Steam, WFI, and BAS Monitoring systems
1/2004 – 5/2012
Facilities and Equipment Engineer / Validation Engineer, Bristol-Myers Squibb, New Brunswick NJ
Worked to initiate, develop, and implement, quality/validation systems for a new pilot plant facility from construction through production use. Commissioned/qualified/validated utility, facility, and eqpt systems for new bldg
Participated in, initiated, and closed out various Change controls, root cause analyses, events, deviations, investigations, risk assessments, gap analyses, FMEAs, and corrective actions preventative actions (CAPAs)
Worked with spare parts system, PM system, calibration system, & work order system for utility & eqpt systems
Managed Validation Resources and the validation of portable equipment on site
Wrote, reviewed, and executed Installation Qualifications, Operational Qualifications, and Performance Qualifications, generated reports, ran tests, worked with the control and monitoring systems and instruments, and analyzed lab results for various facilities, equipment, and utility systems
Familiar with testing and maintaining systems including: HVAC, Instrument Air, Process Water, Glycol / Syltherm, Vacuum, Process Control Systems (DeltaV), BAS, and CIP.
Develop Operating Instructions (OIs) and SOPs for several pieces of equipment and VMPs for various facilities
Aligned different groups such as safety, research, development, engineering, maintenance, and operations to successfully carry out qualifications/validations
Experience using various testing inst. including multimeters, metal analyzer guns, oxygen analyzers, Kaye Validators, and flowmeters.
5/2000 – 12/2003
Validation Engineer, Lockwood Greene, Somerset NJ
Developed and executed Construction Turnover Packages, reviewed P&IDs and Piping Isometric diagrams
Commissioned facilities, utilities, and equipment systems, including collecting and evaluating vendor info & testing, maintaining and updating drawings, and generating and maintaining instrument/valve & spare parts lists
Wrote, reviewed, and executed Installation Qualifications, Operational Qualifications, and Performance Qualifications for various facilities (bulk solvent, API, pilot plants), wrote, reviewed, and implemented SOPs
PROFESSIONAL QUALIFICATIONS
Lean Six Sigma Green Belt Certified
Completed PMI CAPM course, certification pending.
Trained in ISO 9001:2008 with the addition of TS 16949 and knowledgeable in Project Management basics
Experienced with Pharma (21 CFR Part 210 & 211), Electronic (21 CFR Part 11), and Med Device (21 CFR Part 820 / ISO 13485) regulations
Familiar with various Process Control Systems such as DeltaV and Fieldbus systems.
Knowledgeable in Microsoft Word, Microsoft Access, Microsoft Excel, PowerPoint, and Microsoft Project.
EDUCATION
1996-2000
BA Biology, Minor in English, Rutgers University, New Brunswick, NJ