Project Customer Service

Bakul Parikh

Telephone: 919-***-**** Email: *************@*****.***

Professional Summary

Professional with proven track record of leading, managing and working with global team. M ore than 25 years of demonstrated

experience, accomplishments with progressive responsibilities in engineering, project life cycle management, GMP and plant

automation seeking a position where technical and management skills can be challenged. Well experienced with GMP including

developing policies, processes, SOPs, templates, forms, standards, and guidelines, as well as in requirements gathering,

management, and traceability. Experience in driving initiatives on cross-functional teams, performing organizational training,

working with internal and external customers in engineering operations, process control, system integration, engineering for

clients in Asia, Europe and South America and field deployment. Proficient at providing clear direction within organizational

goals.

Areas of Expertise

• • • •

Medical device and Machine and Plant Project management FDA GMP

Pharma industry automation

• • • •

Team leadership and Product life cycle System design and Vendor management

mentoring management system integration and contract

• • • •

Troubleshooting International startups Lean Sigma trained Technology transfer

• • • •

Validation MES implementation IT Systems upgrades Risk assessment

Career Experience

GlaxoSmithKline, RTP, NC.

Secondary Process Automation Engineer Sep 2007 – Present

Authored more than 575 GMP documents and archived more than 500 documents to repository.

Engaged in delivering worldwide eLogbook project using Delta V and Syncade (MES project)

Managed project to design a global solution for MES device project - $200k

Completed Yellow belt training modules.

Using OE principles in pilot plant and R&D to enhance the performance by implementing eLogbook to reduce

the burden of paper logs.

Responsible for delivery of SPA (secondary Process Automation) projects in North America NC and PA) and

London sites.

Certified as Lead Investigator to effectively manage deviations.

Key point of contact with the business with responsibility for service, maintenance and support of SCADA,

DCS, EMS, AMD and SIPAT.

Project Manager for upgrading Environmental Monitoring system (PCS7 and AMS) in UK app $500k

Lead the design, installation and expansion of Pilot plant automation systems, develop and optimize operation

and maintenance procedures for instrumentation and control systems.

Set up comprehensive support and administration for automation and IT systems worldwide for existing and

ever expanding automation systems in R&D pilot plants.

In cooperation with the appropriate PD quality, validation groups and 3rd party suppliers, manage the

development of validation documentation and implement validation plans.

Responsible for identifying issues and suggesting corrective action within projects and develop training

programs for North America.

Responsible for ensuring adequate system maintenance, validation and compliance.

Responsible for managing the service/support contracts and maintaining effective relationships with the 3 rd

parties throughout the lifecycle of the system.

Interface with users, peers, and management to ensure appropriate input and integration of local and

corporate standards.

Provide technical expertise during regulatory audits (Involves life cycle documentation, validation status and

business continuity plan preparation)

Author, review, revise, or approve Standard Operating Procedures (SOP’s), participate on cross-functional

teams, who address specific problems, facilitate discussion and research, enabling procedures to become

more efficient, and to build and enhance interdepartmental relationships.

Bakul Parikh

Prepared project plans, status reports, project metrics, and management presentations for senior

management staff. Identified, mitigated, and reported risks, issues, and scope change requests to senior

management.

• Develop requests for proposals (RFPs) and requests for quotations (RFQs) for infrastructure services and

equipment. Source vendors and establish manufacturing contracts for product production.

Coordinate project deliverables across internal departments and external vendors.

Managed Project Leads, Technical Leads, Outsourced Subject Matter Experts (SMEs), Validation Leads, and

Quality Assurance Leads.

Managing a business change that helps us implement a server system well supported by IT resources. This

approach frees up resource to focus on more urgent priorities.

Track project status, schedule, cost and quality to facilitate timely corrective action to minimize schedule

delays, cost overruns, as well as resolve project issues.

Manage vendors and contractors to ensure resolution with utmost details to customer service and

satisfaction.

Provide support during development and clinical batch processing to ensure proper data collection in

historian.

Prepare, execute and summarize validation documentation including Requirements Specifications, Validation

Plans, 21 CFR Part 11 Assessments, Installation Qualifications, Operational Qualifications, Performance

Qualifications, and Traceability Matrices

Consistently identify the opportunity to study and bring in latest technology in the Secondary pilot plants.

Provide training and technical support to users. Manage training support and problem resolution with the

users in place regionally and globally.

Responsible and accountable to provide automation support and maintenance for SPA systems in US and

UK.

Manage incident management for the SPA systems and accountable for resolution to meet or exceed

expectation of the stakeholder.

Mentor and coach SPA administrators, engineers, PD Scientists as well as calibration technicians to support

Data collection initiative for the batches produced in US and UK Secondary pilot plants.

Excellent Project management for all project deliveries

BioMérieux, Inc, Durham, NC. Apr 06 – Sept 07

Sr. Project / Process Engineer

Managed to identify, prioritize and execute capital improvement projects on time and under budget.

Provided technical leadership, guidance and engagement for maintenance technicians and production

operations team.

Leading continuous improvement efforts in processes in support of facility objectives of safety, quality,

cost and service.

Project lead for the new labeler to manage project team activities involving risk analysis, change requests,

validation, IQ, OQ and PQ, justification and recommendation for facilities.

Lead project to network the Allen Bradley PLC’s within the facility and managed to obtain real time data to

identify downtime and efficiencies of the machine.

Installed vision systems to enhance quality of the product, raw material and reject the non-compliant

product.

Instituted a companywide automation network and started a project to install web cameras at strategic

locations to monitor downtimes. Connected several PLC’s and a real time production counter over the

network.

Wrote and executed URS, FDS, FAT, IOQ, PQ documentation for check weighing systems and high

speed labeling machine. Coordinated all efforts with the cross functional team and vendor.

Author, review and revise standard operating procedures, generate change controls and manage the

entire aspects of its successful completion till closeout.

Provide manufacturing support to meet daily goals on priority basis which included working odd hours and

weekends.

Travel local and international to perform factory acceptance testing, checking out interfacing when

multiple systems are involved and ensure proper documentation to meet GMP specifications.

Manage stakeholders and project implementation and effective issue resolution .

Bakul Parikh

Harris Corporation, Morrisville, NC. Aug 04 –

Apr 06

Project Engineer

Managed cost, schedule, team resources for microwave radio installation through all phases from

proposal to production and final implementation. Manage more than 7 (seven) projects at a time

Background in telecommunications and data network architectures including working with

Switches, Routers and network operations management systems

Track project and program performance against schedule and budget and lead project team to

successful technical and financial completion of each project

Responsible for project team leadership, project management, budget and schedule management,

risk mitigation planning, problem identification and resolution

Interface with the customer, vendors and develop new business opportunities. Responsible for

technical performance, customer satisfaction, profit/loss and program growth

Successful in negotiating contracts with vendors and customers due to good understanding of

networking design and tools

Administer contract terms & conditions as required through project cycle. Supervised a staff of 5

(Five)

System integration to ensure compatibility with customer’s existing system

Education, and past experience

Bachelors of Science in Electrical Engineering

1979

College of Engineering Pune, India

Held four past positions

Freudenberg Nonwovens, Durham, NC, Sep 02 –

Aug 04

Square D, LaVergne, TN, Apr 01 – Sep 02

Alcatel Telecommunications Cable, Claremont, NC Dec 96 – Mar 01

Hudson Valley Tree, Newburgh, NY Dec 91 – Dec 96

Held two positions in Mumbai, India at ABB & Larsen & Toubro Ltd May 79 –

Dec 91

Electrical and Instrumentation, electrical engineering, troubleshooting, preparing P&I diagrams, Modicon PLC

programming, Control panel design, component selection, installation, startup of cement plant, Marine unloaders,

coffee agglomeration plant, PVC plant, Captive power plant, Pharmacy plant. ISO 13485

Contact this candidate