Chemical Engineer

SUMMARY
  • Process driven Chemical Engineer with over 20 years’ experience/success in quality systems, process management, technology transfer and scale-up, project management, equipment validation, and cleaning validation. 
  • Extensive experience in batch processing with a focus on process innovation, cost management, quality assurance, and managing new process/product introduction into full scale production. 
  • Team Leader with experience in leading validation team responsible for qualification of production equipment and process validation as part of remediation effort. 
  • Led the Cleaning Validation Team, prepared Cleaning Validation Master Plan, developed and implemented cleaning procedures to ensure successful cleaning verification results, for an automated API plant.  
  • Completed Six Sigma Green Belt training and certification program. 
  • More than 20 years’ experience in the manufacturing of active pharmaceutical ingredients, solid dosage and aseptic manufacturing in a cGMP environment, including preparation of regulatory dossiers for internal and FDA audits.  
  • Accomplished team manager skilled in leading, coaching, and mentoring teams/ individuals contributors, as well as collaborating with technologists and business partners.  
  • Experienced in working with Global multi-lingual work environments. 

Keywords:

GMP, validation, manufacturing

 

EXPERIENCE

CONSULTANT – PHARMACEUTICAL MANUFACTURING

2012-Present

Sep2017-Dec2019

PFIZER, McPherson, KS
  • As a part of the Aseptic Process Improvement team, carried out observation of the setup, production, breakdown and cleaning operations and recommended corrective actions.
  • Obtained management approval and funding for executing identified CAPAs.
  • Developed Change Control documentation and obtained approval & initiated Action Items. 
  • Implemented process improvement changes with regular weekly follow-up meetings with impacted colleagues and stakeholders. 

Dec2016-Jun2017

PHARMACHEM (GILEAD CMO), Freeport, Bahamas
  • Prepared new Validation Policy for the organization.
  • Created a Site Validation Master Plan. 
  • Authored new SOP’s for qualification of systems and updated existing SOP’s to align them with the new Validation Policy and SVMP. 
  • Created templates for qualification protocols and summary reports. 
  • Prepared Cleaning Validation Plan and Process Validation Plan. 

Jul2016-Oct2016

XELLIA, Cleveland, OH
  • As leader of the CQV team, completed the OQ for the Packaging Line. 
  • Directed team of 6 engineers to write 7 different protocols for the modules of the line.
  • Planned and monitored the execution of the protocols
  • Reviewed deviations, reports and expedited approval from client SME and QA. 

Mar2016-Jun2016

TEVA, Budapest
  • Member of remediation team responsible for equipment qualification in aseptic manufacturing plant.
  • Authored qualification protocols for investigation of filling machine functionality. 

Nov2015-Jan2016

MYLAN, Nashik, India
  • Authored SOP for CPV (Continued Process Verification) and CPV protocols for pilot product Metoprolol ER. 
  • Prepared the CPV Plan for post-PPQ execution per FDA guidance document.

Jun2015-Nov2015

PFIZER (Meridian), St. Louis, MO
  • Conducted Manufacturing Investigations for QA department to establish the true root cause of deviations and recommend corrective/preventive actions (CAPAs). 
  • Participated in cross-functional M1 investigation teams to determine root cause for complex issues. 
  • All investigations were reviewed and approved within the allocated time of 30 days. More importantly, the CAPAs that were identified led to no further recurrence of the incidents. 

 

Sep2014-May2015

NOVARTIS CMO, Durham, NC 
  • Prepared detailed User Requirement Specifications (URS), Functional Requirement Specifications (FRS) and Design Specifications (DS) for Facilities, Utilities, Manufacturing Equipment and Filling Equipment. 
  • Authored IOQ protocols for the manufacturing equipment and facilities and utilities. 
  • Revised and wrote new SOP’s as applicable. Prepared new Master Batch Records to meet cGMP standards.  
  • Executed IOQ protocols and prepared summary reports. 
  • Prepared PQ protocols, monitored execution and preparation of summary reports.

Nov2013-Jun2014

IMPAX, Hayward, CA
  • Authored IQ / OQ protocols for Facilities, Utilities and Manufacturing Equipment. Executed the protocols and wrote the final reports. 
  • Prepared validation documents and qualification protocols for Shared Utilities: Process Water, Compressed Air., and Nitrogen. Monitored the execution of the protocols and prepared final qualification reports.
  • Authored protocols for the qualification of renovated manufacturing suites. Monitored the Environmental Quality testing of those manufacturing areas with newly installed HEPA filters. Performed non-volatile particulate testing to expedite the release of the rooms for manufacturing use. 
  • Prepared the exception reports, obtained QA approval and wrote final summary reports for release of the renovated suites for manufacture. 

Mar2012-Oct2013

NOVARTIS, Lincoln, NE
  • As member of validation leadership team, reviewed Site Validation Master Plans for Site, and provided guidance in preparation of the Equipment Validation Master Plan and the Cleaning Validation Master Plan.
  • Prepared Impact / Risk Assessments and Gap Analysis Reports to meet cGMP guidelines. 
  • Prepared addenda to executed protocols at client’s request to complete qualifications of modifications made on equipment during remediation activities. 
  • Leader of team that authored IQ / OQ protocols for Manufacturing / Packaging Equipment. Monitored progress of protocol execution and report approvals versus schedule. 
  • Attended daily meetings with client’s product start-up team to report on progress and meet corporate goals. 
  • Finalized the PQ protocols for Packaging Equipment. Held meetings with members from shop floor operations, shop floor QC, process engineers and QA to incorporate their observations into protocol. Trained client engineers on protocol execution, deviation reporting and summary report writing. 
  • Prepared validation documents and qualification protocols for Shared Utilities: Process Water, Compressed Air., and Nitrogen. Monitored the execution of the protocols and prepared final qualification reports. 
  • Completed the qualification of R&D Pilot Lab equipment 

 

PIRAMAL CRITICAL CARE, Bethlehem, PA (June 2011-March 2012) Engineering Consultant

Generic manufacturer of inhaled anesthetics. 

Primary responsibility is to provide leadership for the process design, equipment identification, procurement and installation of production equipment for the introduction of a new generic anesthetic drug. 

  • Established process flow diagram for new product and got buy-in from stakeholders. 
  • Designed and ordered major long lead equipment items for the new equipment train.  
  • Designed, ordered, built and commissioned new process equipment for company’s established product to improve quality and productivity.
  • Investigating the quality of waste water with the objective of establishing a treatment protocol. 
  • Responsible for realignment of equipment trains to meet production goals with minimal capital expenditure.  
  • Leading the initiative to improve the PSM process with respect to MOC’s.

 

BRISTOL MYERS SQUIBB, Devens, MA Validation Consultant

  • Completed validation studies for autoclaves for new plant being commissioned in Devens, MA.

 

 

VERENIUM CORP., Cambridge, MA (2008-2010) Senior Manager, Process Engineering

New business start- up, developing and commercializing a Bio Fuels Cellulosic Ethanol process; acquired by BP. 

Led the propagation area for newly constructed and commissioned demonstration plant that was built to prove and sell the technology to produce ethanol from bagasse and other non-food inputs. 

  • Acted as Senior Project Manager responsible for planning, scheduling, and managing internal resources and external vendors for the startup of the propagation department, the critical third phase in a six phase process for the new construction, start-up, and commissioning of Jennings LA demonstration plant. 
  • Problem-solved and resolved complex issues related to procurement, manpower planning, and technical discrepancies, resulting in the successful commissioning in time to supply enzymes and inoculums for the plant. 
  • Partnered and coordinated activities between Operations, R&D, vendors, and engineers to manufacture enzyme batches, achieving all performance milestones. 
  • Led the initiative to double capacity of the Enzyme manufacturing unit, allowing the demonstration plant to achieve the plant’s goal of producing 1.5mgy of ethanol.

  

PFIZER, INC., Groton, CT (1992-2008) Technical Manager

Fortune 100 company; Global Research and Manufacturing pharmaceutical company.

Responsible for managing, problem-solving, and resolving all technical issues, ensuring the highest process and product integrity for the 24/7 batch processing manufacture of pharmaceuticals.

  • Performed Quality Engineering by re-engineering and improving the Step 2 manufacturing process for Draxxin.  Utilized and participated on a Six-Sigma cross-functional project team to resolve the number one technical issue of high Epimer impurity levels. 
  • Completed a Quality Investigation by analyzing and reconfiguring the Step 3 Draxxin process using problem-solving and change management techniques, resulting in a 115% batch size increase and positioned the division to meet its supply chain commitments. 
  • Executed a Quality Improvement program by optimizing the Step 2 Draxxin process, incorporating several changes that resulted in cost savings of approximately $1.25M annually. 
  • As a Quality Initiative, joined a Six-Sigma Black Belt team that addressed and resolved an environmental issue associated with the control of ethylene gas emissions produced in the Draxxin process.  
  • As Quality Leader, led a Product-based Capability Analysis team responsible for establishing the process capability of the Draxxin process.  This was a major project in the Right First Time (RFT) initiative that the division had embraced in collaboration with the FDA. 
  • Led the team that created the new template for carrying out investigations as per the DMAIC approach. 
  • Completed two major projects (installation of guard scrubber and installation of Continuous Emissions Monitoring System) as part of the plant’s requirements to meet the new pharmaceutical MACT regulations that came into force in October 2002.  
  • As Leader of the Cleaning Validation Team, prepared a Cleaning Validation Master Plan for an automated API plant. Developed the cleaning procedures to meet plan requirements and to improve the efficiency of time between production runs / campaigns. Supervised a team of three technicians for preparation of all the required documentation for the cleaning and changeover activities in the plant. Worked with the Automation group to develop automated cleaning procedures for greater consistency and repeatability. Investigated all cleaning verification failures and developed and implemented corrective actions, 
  • Developed and utilized detailed planning techniques to minimize down-time between campaigns.
  • Led a Continuous Improvement team to resolve issues faced in set up and equipment cleaning activities. 
  • Transferred production of Neurontin from a manually operated plant in Holland, MI to the computerized facility in Groton, CT, achieving all time and cost objectives. 

 

 

NOVACOR CHEMICALS, Leominster, MA (1991-1992) Process Engineer

Manufacturer of chemicals for the plastics industry.

Managed multiple projects and processes for this continuous process manufacturing facility.

  • Executed multiple projects totaling $100K during maintenance over shut down of plant, completing all projects on time and within budget.
  • Analyzed and completed performance trials for raw material substitution, resulting in annual savings of $50K. 
  • Designed and implemented modifications to a reactor, resolving a major cause of plant shut down. 
  • Improved process control and environmental compliance through the modification of plant design. 
  • Developed and implemented a zero discharge process for recycling of wastewater effluent.

 

HERDILLIA OXIDES & ELECTRONICS, Bombay, India (1989-1990) Project Manager

Project Manager

Implemented a joint venture, $15M project with Magnox Inc. for the manufacture of Magnetic Iron Oxides. Finalized selection of equipment, obtained approvals from financial institutions, recruited key supervisory staff, and established liaison with environmental control agencies.

 

POLYNOVA INDUSTRIES, Bombay, India (1988-1989) Project Manager

Installed and commissioned a vinyl fabrics plant imported from Ramisch Kleinwefers Gmbh, West Germany.  Completed project on schedule and stabilized production within two months while meeting cost and volume targets.

 

Prior Experience: 

GOODLASS NEROLAC PAINTS, Bombay, India - Production and Planning Manager

HAWKINS PRESSURE COOKERS, Bombay, India - Engineer

 

EDUCATION

Master of Business Administration, Operations Management, INDIAN INSTITUTE OF MANAGEMENT (IIM), Calcutta, 

Bachelor of Science, Chemical Engineering, Honors, INDIAN INSTITUTE OF TECHNOLOGY (IIT), Bombay, India

 

ADDITIONAL TRAINING

Statistical Methods in Management, Operations Management, WORCESTER POLYTECHNIC INSTITUTE, Worcester, MA

Fundamentals of Project Management, Essential Facilitation and Basics of Drug Development, PFIZER TRAINING COURSES

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