Pharma and Biopharma manufacturing

SIVA NALLENDRAN

Contact Details

Address : */***, *** ***** ******, NAGAMANAICKENPATTI (POST), THURAIYUR (TALUK), TRICHY (DISTRICT), TAMILNADU (STATE), INDIA 621001 Mobile No. : +918********* +919*********

Email : ************@*****.***

Personal Particulars

Age : 40 years

Date of Birth : 15 June 1982

Nationality : India

Gender : Male

Marital Status : Married

Passport Number : Z3808625

Education Qualifications

IIT-M Certified Advanced Programmer with Data Engineer Mastery Program Institute/University: Guvi Geek Networks @ IITM Research Park, Chennai - 600113 Passing Year : Pursuing

Education Stream : Live Online mode

NEBOSH HSE Certificate in Process Safety Management Institute : Bharat Safety Training, Kuwait

Passing Year : Pursuing

Education stream : Online mode

Master in Environmental and Occupational Healthy

Institute/University : Indira Gandhi National Open University, Maidan Garhi, New Delhi – 110068. Graduation Year : Pursuing

Education stream : Distance mode

B.Tech., Chemical Engineering

Field of Study : Chemical Engineering,

Institute/University : J.R.N. Rajasthan Vidyapeeth (Deemed) University, Udaipur, India 313001 Graduation Year : Mar 2016

Education Stream : Distance mode

Certificate in Commissioning and Qualifications of Equipment and Systems

(WSQ Programme “Develop Validation Protocol for Equipment PI-PH-308E-1” Accredited by the WDA) Institute/University : DPS Engineering Singapore

Passing Year : Mar 2016

Education Stream : Online mode

Specialist Diploma in Pharma and Biopharma Manufacturing Field of Study : Pharmaceutical and Biopharmaceutical Manufacturing, Institute/University: NGEE ANN POLYTECHNIC, Singapore 599489 Graduating GPA : 2.4286 out of 4

Graduation Year : May 2012

Education Stream : Part Time

Diploma in Chemical Technology (Sandwich)

Field of Study : Chemical Engineering

Institute/University : Institute of Chemical Technology (Central Institutes of Technology Campus), Chennai - 600113 Grade : First Class

Graduation Year : Oct 2004

Implant Training : Madras Fertilizers Limited

Duration : 21 Jun 2004 to 20 Oct 2004

Education Stream : Full Time

Higher Secondary

Field of Study : Science (Physics, Chemistry, Botany, Zoology & Languages i.e., English and Tamil) School : Sengunthar Higher Secondary School, Thuraiyur, India 621010 Grade/Percentage : 63%

Graduation Year : Mar 1999

S.S.L.C.,

Field of Study : General (Science, Social Science, Mathematics & Languages i.e., English and Tamil) Institute/University :A.G.M. High School, Eragudi, India 621001 School : 78%

Graduation Year : Apr 1997

Experience

Experience Level : Total 10 Plus Years of Experience in manufacturing industry Employment History:

Previous Employment 3

Company Name : ROCHE SINGAPORE TECHNICAL OPERATIONS, Position Title : Manufacturing Biotechnologist II, Specialization : Manufacturing/Production Operations, lndustry : Biologics,

Duration : Jul 2013 – Jul 2017 (In Media & Buffer Prep) Jul 2017 – Sep 2019 (In Upstream Processing)

Work Description

•Supporting the Biochemical Manufacturing Department by working effectively within the group to meet department goals and Objectives.

•Responsible for completing assigned tasks which may include preparing small equipment cleaning and sterilizing vessels,

preparing solutions, monitoring the operations of biochemical processing equipment, raw materials sampling and Environmental monitoring sampling while adhering to safety, cGMP and Biochemical Manufacturing guidelines.

•Prepare buffers or other process materials.

•Using the understanding of process theory to perform and monitor critical processes.

•Proficient in the operation and use of appropriate equipment in the area.

•Tasks are assigned and work must be documented per approved manufacturing formulae using Good Documentation Practices (GDP) with appropriate SOPs and log books.

•Participate in resolving problems during operations.

•Escalate any issue encountered with equipment or process.

•Support process improvement efforts.

•Assisting with system ownership responsibilities.

•Operate Delta V for process control and computer for the SAP transactions & data entry.

•Comply with cGMP and the Plant’s Environmental, Health, Safety and Quality (EHSQ) guidelines.

•Participate in staff and shift change meetings and work closely with other shift personnel and external support groups.

•Will draft, own and revise documents such as SOPs and review documents for assigned tasks (e.g. Equipment log book and Batch Record and Routine are audit).

•Training staffs to perform hands-on tasks.

• Experience with Emerson Delta V, LIMS &equipment. TrackWise.

•Ability to perform computer operations, such as ability to navigate in MS Office and complete Computer Based Training(CBT).

•Ability and Willingness to work any shift in support of operations that may include 24/7.

•Experience and Strong troubleshooting skills with laboratory and process. Previous Employment 2

Company Name : DENKA SINGAPORE PRIVATE LIMITED,

Position Title : Process Technician

Specialization : Manufacturing/Production Operations Industry : Petrochemical

Duration : Nov 2012 – Jun 2013

Work Description

•To achieve operational KPI’s through shutdown, start up, troubleshooting activities and operational improvement program.

•Field and Board operations to achieve safety, quality and production targets in accordance with organisational policies and procedures.

•Operate production equipment ( through Yokogawa DCS CS1000 & Centum VP) in assigned area In accordance to SOP Procedures.

•Handle daily operational tasks and participate in plant troubleshooting.

•Monitor and control plant production activities.

•Perform field logging & routine sampling.

•Undertake minor maintenance and prepare process equipment for major maintenance.

•Comply with the Plant’s Environmental, Health, Safety and Quality (EHSQ) guidelines.

•Work in Production environment and interact with technical teams to resolve problems. Previous Employment 1

Company Name : WYETH NUTRITIONALS (SINGAPORE) PRIVATE LIMITED, Position Title : Production Assistant

Specialization : Manufacturing/Production Operations Industry : Nutritionals

Duration : Jun 2009 – Oct 2012

Work Description

•Responsible in assisting the proper start-up or shutdown of the spray dryer and evaporator units.

•Co-ordinating with E & I people with respect to the Safety Work Permit System.

•Regular check up of product quality specs with the in-process laboratory.

•Documenting the plant operations.

•Following the MSDS and SOP.

•Following the hygiene practice in the plant according to cGMP Requirement.

•To carry on the production according to Production Planning.

•To assist in the Clean In Place for both the Dryer and Evaporator.

•Maintaining the documents as per USFDA, cGMP Regulation. Availability

•Immediate.

Job Preferences

Expected Monthly Salary : $$ Negotiable

Willing to Travel : Will Consider

Willing to Relocate : Will Consider

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