Engineer Management

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

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