Project Manager Engineer

Mohanad Hasan

*** ******* ***. *********, **, ***20

Tel: 201-***-**** Email: ************@*****.***

Job Objective: To ensure a Pharmaceutical Manufacturing Engineer position

within a fast growing industry in which my science-based knowledge can help

the business meet its goals.

My style is ISTJ (Introverted, Sensing, Thinking with Judging)

SUMMARY OF QUALIFICATION

. A good scientific and technical knowledge in drug manufacture,

pharmaceutical process design, FDA guidelines, CFR 21, and cGMP

requirements

. Deep knowledge of various drug chemical composition, structure and

properties

. Familiarity with CIP and SIP Cycle Development, SOP, PAT, DOE, CAPA, ISO

5, ISO 8, Aseptic Vial Filling, OSD form, Packaging, Lean Six Sigma,

Process Validation, Equipments Qualification (IQ; OQ; PQ), Gantt Chart,

and Project Management

. Proficient with pharmaceutical process equipment, laboratory and/or

technical tools

. Exceptional skills to work on chemical and mechanical systems

. Sound knowledge of drug test method validation and statistical tools

(Minitab)

. Adequate understanding of development processes in own function

. Good knowledge of software and computer tools

. Proficient in literature searches

WORK EXPERIENCE

Nov. 2013- Present

Teacher Assistance: Pharmaceutical Manufacturing Engineering Program,

Stevens Inst. Tech.

Jan. 2013-- May 2013 (5 months)

Project Manager at Stevens Pharmaceutical Research Center (SPRC) for

production Cocoa Tablet

Stevens Institute of Technology Hoboken, NJ

. During product design phase created and analyzed DOE for formulation as

well as for manufacturing process, analytical method and cleaning

procedure

. Based on DOE, determined design space to reduce the need for Change

Control

. Created fishbone (Ishikawa diagram) and Risk Assessment (FMEA) for each

step of process to determine Critical Process Parameters (CPPs) required

obtaining quality product

. Using FMEA developed Validation Masterplan and developed and executed

equipment qualification (IQ, OQ, PQ) and Process Validation (PV)

protocols

. Performed recovery studies to develop cleaning validation method of an

API using TOC analyzer

. Managed documentation as a Systems Administrator of EDMS and created

document-workflows to speed up approval of documents

Oct. 2009 -- Present

Medical Billing and Coding Instructor, Drake College of Business School,

800 Broad Street, Newark, NJ, 07102, USA

. Preparing lesson plans by using State standard

. Educating and training students by using accepted and approved

instructional methodology

. Reporting the Campus Director of Education

Apr. 2008- Aug. 2009 (1 year and 4 months)

Quality Assurance Engineer, Al-Furat Pharma Industry, Baghdad, Iraq.

. Participate in launch development with the supply base to ensure smooth

transitions of new productions and components

. Supervise and execute activities related to reviewing, monitoring and

assessing the integrity of a contract manufacturer's adherence to the

manufacturer quality expectations

. Contribute on cross functional teams to assure effective implementation

and adherence of QA initiatives

. Develop and maintain relationships with management at Contract

Manufacturing facilities in order to drive continuous improvement efforts

Feb. 2006- Mar. 2008 (2 years and 1 month)

Validation Engineer, Baghdad Pharmaceutical Manufacturing Company, Baghdad,

Iraq.

. Develop, and prepares validation protocols to challenge the all types of

processes for validation of manufacturing and packaging processes, as

well as cleaning processes

. Execute and assist in execution of validation protocols which consists of

taking finished product and bulk samples, swabbing equipment surfaces for

cleaning evaluation, and evaluating packaging processes

. Equipment qualification execution entails analyzing equipment performance

against stated performance criteria.

. Monitor regulatory and inspection trends and advice the business on

suitable action

. Review validation deliverables for projects which are contracted to third

party suppliers

. Compile and analyze analytical validation data and test results and

prepare documentation that meet established specifications and quality

standards

. Participate in establishing standard quality and validation practices

. Attend meetings with production, packaging, engineering, quality

assurance and research and development personnel to obtain the necessary

information for protocol preparation

. Review detail of change activities for equipment qualifications and

decides on revalidation requirements

Jan. 2002- Feb. 2006 (4 years and 1 month)

Associate Head of Department and Lecturer, Biochemical Engineering

Department, University of Baghdad, Baghdad, Iraq

. Supervise the Department Examinations and Purchasing Committees

. Organize Engineering Seminars and Exhibitions on latest trends in

Chemical Engineering

. Supervise the planning of course offerings and schedules of the

department

. Prepare the bi-weekly progress report of the department, including action

points and recommendations to the Dean Office

. Teach Mass Transfer, Heat Transfer, and Fluid Flow courses

. Prepare syllabuses and deliver in time

. Represent of the college in Forums, Seminars, and Conferences

EDUCATIONAL BACKGROUND

Dec. 2013 Master's Degree in Pharmaceutical Manufacturing Engineering,

Stevens Institute of Technology, Hoboken, NJ, GPA (3.97)

Feb. 2006 PhD in Chemical Engineering, University of Baghdad, Baghdad, Iraq

TRAINING COURSES ATTENDED

. American Medical Association AMA workshop of ICD-10 Coding (Dec.2013)

. NHA membership, National Healthcare Association certification in Medical

Billing and Coding 2014

. OSHA, Annual Bloodborne pathogens Training (Apr. 2013)

. Computers in the Medical Office Using Medisoft Advanced Version 16. (Oct.

2010)

. Internal Quality Auditor Certification from Ministry of Planning (Iraq

Sep. 2002)

Contact this candidate