Engineer Engineering

Raza Ali Syed

***, ******* **** ****** *******

Newyork-10989

Home Telephone # 1-845-***-****

E-mail: *******@*******.***

HANDS ON & RESULTS-DR IVEN PROCESS ENG INEER

• Experienced process engineer w ith many years of success in propelling breakthrough process

i mprovements and bottom-line gains for Pharmaceuticals, Food and Personnel care industries.

• Expert in systems/process design & improvements, cost-reduction strategies and energy-

saving solutions. K nown for innovative problem solving and complex troubleshooting.

KEY SKILLS & KNOWLEDGE AREAS

• •

• Plant engineering management Execution of validation Experienced in electrical and

p rotocols IQ/ OQ /PQ for mechanical maintenance,

and operation.

• Development of equipment systems, processes, t roubleshooting, modification,

equipment, cleaning, critical upgrading, and hydraulics.

specification, selection and

u tilities and facilities. Pneumatics and P LC control

j ustification.

systems.

• Capital engineering projects from

• Development and

i nception to validation.

•

i mplementation of PMs, Design and develop

• Installation, commissioning and SOPs, Packaging Component Pharmaceutical & WFI water

operation of production machines and Specification, Calibration / systems with specialized

equipment including L yophilizer, Verification and Preventive p lumbing to meet different

p rocess and packaging equipments of M aintenance procedures for water standard specifications.

solid dosage, liquid and aseptic p rocess and packaging

•

manufacturing, blending / filling Application of multiple process

equipment.

machinery, and packaging i mprovement tools including

• Plant design layout

conveyors. SPC and DOE to resolve root

• Modifying & upgrade machines i ncluding space planning for causes of manufacturing

new facilities and p roblems.

and equipment to economically

i mprovement in existing

p roduce new/ existing product

• Application of lean six sigma

ones.

and to increase overall

methodology.

performance of equipment .

• Supervision and

coordination of activities of

engineering personnel

EXPERIENCE

Senior Process Engineer 9/2000 - Present Manufacturer of Reagent Products New

York

Worldwide Company Best Performance Award in engineering.

Best Accomplishments (Year 2000-2013)

D esigned, developed and fabricated :

o o

Tonometry Controller for New Pharmaceutical & WFI water

P roducts. system with specialized plumbing to control

o bacterial growth.

Filling equipment for10kg Tester

o In-line heat exchanger to improve

bags.

o p roduct quality.

Pressure control systems.

Continuous I mp rovements projects:

Successfully installed and validated a non functional fill and seal machine.

Successfully improved pouch valve insertion machine to meet tight valve insertion specification.

Cu r rently working to imp rove th roughput of a custom made fill and seal machine

t o 99.5%.

Key Responsibilities:

Direct all aspects of daily plant engineering operations and management.

Identify savings/improvement opportunities and solve challenging technical, process-f low and resource-

limitation problems.

Provide technical engineering support to engineering & manufacturing departments in the improvements

of all plant systems, facilities and processes and in the specification of equipment.

Apply process-engineering expertise to ensure that manufacturing processes are appropriately scaled,

t ransferred and implemented; perform reliably; and remain in a state of compliance.

Apply knowledge of cGMPs, process characterization, validation, and statistical process control towards

generation review, and/or approval of compliance documents.

Apply engineering principles and knowledge of process unit operations and process equipment to evaluate

p rocess excursions or trends. Evaluate appropriate data and design and execute necessary experiments to

assess product impact and preventative actions.

Ensure safety standards are met within the facility and forge technical investigations into any problems

t hat may arise with products or processes.

Selection of process and packaging equipment, justification, installation and startup.

Design new plants layouts and improved the existing ones to maximize space utilization and to improve

t he process flow.

Develop Standard Operating Procedure, Packaging Component Specification, Preventive Maintenance

P rocedure and Calibration &Verification Procedure for process & packaging equipment including plant

u tilities.

Write, execute and summarize validation protocols IQ/OQ/PQ for systems, processes, equipment,

cleaning, critical utilities and facilities to ensure cGMP and FDA requirements for validation are met and

maintained over time.

Write and execute Change orders, Corrective actions and NODADs.

Plant Engineer 03/ 2000 - 07/ 2000 KEYSTONE CAPS CO LANCASTER, PA

Job Responsibilities

Designed, developed and implemented cost effective manufacturing processes.

Developed preventive maintenance program for equipment.

Provided technical engineering expertise to production and maintenance departments.

Effectively utilized available resources to improve performance of plant utilities and equipment

operational capability

Provided practical solutions of system problems through troubleshooting, upgrading and modification.

Project Engineering Manager (06/1990 – 11/1999) MASCOT ENGINEERING PAKISTAN

Key Responsibilities

Successfully managed, coordinated, implemented and completed many capital engineering projects from

i nception to validation.

Prepared cost analysis and estimated timelines of engineering projects

Developed and documented all project engineering analysis, design calculations and reports to meet GMP

QA requirements.

Coordinated and assisted in arrangement of necessary resources to ensure timely project completion.

Designed new plant layouts and improved existing ones to maximize space utilization and to improve the

p rocess flow. Conducted space planning meetings to update team leaders about ongoing and upcoming

p rojects in their respective areas.

Established equipment design specification to meet the specific process / product needs.

Effectively involved in selection of process and packaging equipment’s, justification, installation and

startup.

Installed process and packaging equipment for solid dosage, liquid and aseptic manufacturing including

p lant utilities - Cooling tower, Air compressor, RO & DI Water systems, and Distillation units complete

w ith point of use piping and controls.

Supervised outside contractors, vendors, engineering personnel and technicians involved in installation,

maintenance and repair work to ensure completion of job in time and within budget.

Inspected jobs in process and at completion to ensure company’s quality work standard and safety were

maintained.

Designed and modified machines and equipment, tooling, fixtures and their components to economically

p roduce new and existing products and to increase the overall performance of the equipment.

Provided technical engineering support to the manufacturing department.

Implemented computerized maintenance management system to control preventive and predictive

maintenance.

Manufacturing Process Engineer (07/1983 – 06/1990)

Key Responsibilities

Designed, developed and fabricated complete pharmaceutical process and packaging

equipment on tu rnkey basis.

Directed and supervised dismantling, overhauling, rebuilding, transportation and reinstallation of

complete plant machinery and equipment at new location.

Rebuilt and upgraded high speed packaging equipment.

Provided technical support for commissioning activities (e.g. receipt verification, factory acceptance

testing, functional testing etc.) and qualification activities (e.g. Design qualification, Installation

---qualification and Operational qualification) as they developed and executed.

Developed Standard Operating Procedure, Preventive Maintenance Procedure, Calibration &Verification

-Procedure for process & packaging equipment including plant utilities.

Earned a reputation as a t rusted technology advisor offering cost-effective solutions through innovative

design and thorough knowledge of engineering tools and techniques.

Assisted in analyzing, specifying and recommending tools and equipment needed to manufacture new /

existing product.

Designed and developed manufacturing processes, methods and techniques to produce new/modified

p roduct.

Provided technical engineering support in troubleshooting, upgrading and modification to keep process

and packaging equipment running to best of its capacity.

Applied statistical process techniques (SPC) & DOE to evaluate and suggest improvements in

manufacturing problems.

Trained engineering and manufacturing staff in continuous improvement activities, product development

and process engineering.

Plant Engineer 01/1982 - 06/1983 Sterling (Winth rop) Pha rmaceuticals

P akistan (Ka rachi)

Achievement: Company Best performance Award in e ngineering operations and

m anagement

K ey Responsibilities

D irected all aspects of daily plant engineering operations and management.

Designed new space layouts and improved existing ones to ensure safe and smooth process flow.

Installed process and packaging equipment for solid dosage, liquid and aseptic manufacturing, including

b lister packaging machinery and conveyors.

Maintained and upgraded production machines and process equipment system controls, and plant

u tilities.

Implemented job order system, preventive and predictive maintenance schedule to improve overall plant

efficiency.

Supervised all activities of engineering and maintenance department.

EDUCAT ION

1981 Bachelor of Engineering (Mechanical - NED University of Engineering & Technology, Karachi,

Pakistan

1974 Bachelor of Science (Major in Chemistry, Statistics, Mathematics and Physics) - University of

K arachi, Pakistan

Certification :

o o

P.E.R.T/ CPM for project control Project management control

o o

M anagement Training I R Welding training by George

o F ischer

QSR / FDA effect on job

o

o Continuous process improvement

ASQ Six sigma green belt

th

certification ( schedule Date : 7 Dec 2013)

TECHNOLOGY

• Microsoft Office (Word, Excel, PowerPoint, Project, ) - Visio

• AutoCAD, Turbo CAD, Minitab, SAP

AFF I L IAT ION :

• Member, Pakistan Engineering Council

• Member, American society for Quality

• Member, Institute of Validation Technology- USA

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