Engineer Project

Objective

I seek a management role in engineering, quality systems or technical

writing.

Personal Data

Citizenshi United States of America DoB: 29 March

p: 1967

Education: Purdue University, W. Lafayette, IN, USA

M.S. Chemical Engineering (1995), B.S. Biochemistry

(1990)

Experience

Present ~ October Macter International Ltd. (Karachi, Pakistan)

2002

09/10 ~ Designation: Head of Compliance & Quality Operations

current

Scope: Lead QA, QC, & IMS functions. Team of 60 persons: 4

direct reports.

Restructured the team to provide increased focus on functional

areas. Supported technology transfer in the induction of 2

additional Toll clients. Reduced cost of manufacturing and testing

through validation initiatives. Established a broad training base

in QA/QC departments. Engaged consultant services for building EHS

system leading towards ISO standard requirements.

09/08 ~ 09/10 Head of Compliance

Scope: Ensured implementation of ISO 9001:2008: 3 direct

reports.

Created & established a Compliance department to manage the audit

function for compliance to ISO 9001 QMS. Developed policy,

procedures and manual for ISO 9001 QMS & EHS programs. Met Toll

client needs through improvements of the quality systems and GMP

compliance. Encouraged transparency and trust level of Compliance

department. Improved customer trust and business prospects and by

supporting and passing external audits of facility systems &

processes. Created a knowledge database populated with references,

standards & best practices. Ensured and conducted internal audits

and external audits of vendor facilities. Established and lead new

validation team; including development of project plans, training,

document formats, protocols & reports. Conducted GMP and Validation

trainings. Lead multiple GMP facility renovations from concept to

validation and start-up.

05/04 ~ 09/08 Process & Compliance Specialist

Scope: Management and commissioning of Capital projects and

renovations. Lead a team of Project Area Leads &

Project Coordinator.

Identified compliance gaps and requirements leading to segregation

of antibiotic operations. Designed (architecture, process and

piping) and managed construction of new penicillin facility (60,000

sq.ft. - Oral and Parenteral dosage forms). Significantly reduced

project costs by maximizing internal resource use to meet project

needs. Designed and qualified new Cephalosporin formulation and

filling area. Designed and managed several facility renovation

projects (OSD, LOC, Aseptic Filling areas). Designed, selected,

installed and validated new WFI water system. Introduced Autocad

capabilities and drawing standards. Coached & developed Project

Manager and CAD designer. Technical advisor in decisions relating

to GMP compliance, equipment selection/purchase, and facility

design issues. Concept design architectural layout for a multi-

product pharmaceutical facility. Designed transfer panel system for

liquid manufacturing and filling. Conducted internal audits for ISO

and GMP.

10/02 ~ 05/04 Head of Production

Scope: Accountable for pharmaceutical production activities

in the facility. 3 direct reports. Total labor staff

of approximately 700 persons.

Directed production activities manufacturing OSD (tablet, capsule,

dry syrup), LOC (syrup, suspensions, ointments) and parenteral

(vials and ampoule) dosage forms. Supported toll manufacturing for

multi-national companies based in Pakistan. Developed and launched

a production planning/control system that measured performance and

provided higher service levels to customers. Optimized batch sizes,

reduced overtime. Established cross-training of Production

supervisors.

July 1996 ~ October Fluor Corporation (Greenville, SC, USA)

2002

11/00 ~ 10/02 Process Engineer II

Scope: Lead Process area design team (self plus 2 engineers)

for biotech process engineering and utility systems

design.

Responsible for managing activities of area team process engineers.

Responsible for supporting estimating activities, conceptual

design, and preliminary design, and detail design. Worked on

engineering design basis, material balance, heat transfer

calculations, and pipe sizing and P&ID design. Designed

biopharmaceutical processes for buffer prep, media prep, cell

culture and harvest, purification and filling. Client processes

included a monoclonal antibody (Isotope labeled) process.

08/99 ~ 10/00 Process Engineer (Consultant)

Scope: Process design & validation engineer at client site

(MD, DE, NJ, USA)

Process lead engineer during conceptual and preliminary engineering

activities for a GMP facility design. Worked on hydraulic modeling

of WFI piping system. Designed PFDs, P&IDs, process descriptions,

preliminary utility calculations preliminary, and equipment

datasheets for client. Validation engineer; generated and executed

validation master plans and prospective process validation

protocols. Evaluated validation data and presented reports to

client. Represented client during an FDA audit of the facility

processes.

07/96 ~ 08/99 Process Engineer I

Scope: Process design engineering of assigned technical

processes including: fermentation, purification and

large scale solution preparation areas.

Participated in conceptual phase design activities of biotech

process including; fermentation, buffer prep, chromatography,

lyophilization, excipient formulation and syringe filling lines.

Designed the fermentation and recovery suite of pilot plant BL2

facility for Client. Responsible for P&ID development and reviews

with Client. Designed the utility summary and wrote process

descriptions. Piping line sizing, design basis development, heat

transfer & material balance calculations. Designing the

purification and formulation process of a biotech facility. Worked

on hydraulic modeling of USP water loop. Included; Heavily involved

in project close-out and detailed design activities. Worked closely

with piping and equipment engineers to specify process requirements

leading to final approval and purchase of major process equipment.

Received an MVP for streamlining tank and vessel design activities.

Responsible for hydraulic design of media supply module of a BL2

class bioreactor for USA Client.

Certifications, Memberships

. Certified Quality Auditor (ASQ) certificate number 40686:2010

. IRCA Lead Auditor of ISO 9000:2000

. Project Management (35 hour course by PMI).

. Leadership C&G Model (20 hour course - Schuitema Institute)

. Process Quality Improvement Tools

. Served on the Advisors Committee for CEMB (University of Punjab) on

a facility design project as a corporate supporter (c. 2007).

. Recipient of MVP award at Fluor Corporation for development of heat

transfer spreadsheets and pipe hydraulic calculation spreadsheets

(c 2001)

Contact this candidate