Engineer Process

Professional Summary

Sharp and innovative pharmaceutical professional with more than six years of experience in Process Engineering, Quality Assurance, Research and Development, and Manufacturing.

Proven track record in delivering projects involving Process Improvement, Validation, and Qualification of Equipment and Facilities.

Hands-on experience in operating process equipment involving Mixers, Blenders, Tablet Presses, Granulators, and Encapsulation Machines.

Areas of Expertise

Validation and Qualification

Cross-Functional Team Collaboration

Operation Excellence (Oral Solids)

Statistical Analysis & SAS (Basics)

Cleaning Validation

Investigations and Deviations

Leadership and Supervision

Troubleshooting Processes

Process Improvement

Strategic Planning

Formal Education

Master of Business Administration, Scheduled Dec. 2016

Saint Xavier University, IL

Master of Science, Pharmaceutical Manufacturing Engineering, 2009

Stevens Institute of Technology, NJ

Bachelor of Science, Pharmacy, 2006

Rajiv Gandhi University, India

Registration/Certifications

Registered Pharmacist, India

Pharmaceutical Manufacturing Practices

Certified Fette Tablet Press Operator Advanced Level (Fette Tablet Press Bi-process Systems)

Notable Accomplishments

WOCKHARDT:

Qualified new Oral Solid-Dosage facility using only minimum task force due to my extensive wide-ranging knowledge of pharmaceutical manufacturing, engineering, microbiology and validation; saving huge costs associated with hiring unnecessary consultants. Prior to Qualification, performed risk assessment of facility and actively participated in problem troubleshooting.

Qualified new facility’s Oral Solid-Dosage equipment such as Tablet Press, Blender, co-mills, Laser Drilling machine and Packaging Equipment.

NOSTRUM LABORATORIES:

Validated entire Process Chain including Dispensing, Blending, Mixing, Compression, Packaging and Laser Drilling.

Decreased unit execution time of granulation operations; reducing sub-lot manufacturing time 20 minutes for each of 10 sub-lots and decreasing unnecessary drying time.

AMNEAL PHARMACEUTICALS:

Increased production approximately 1.5 times by training current unit operators to be more efficient.

In-depth knowledge of QbD Aspects, Process Analytical Technology and Mapping, Root Cause Analysis, Project and Business Process Management, SIPOC, Stakeholder Analysis, CTQ, PERT Charts, Risk Analysis, API Change Projects, FMEA, Design of Experiments (Minitab), PDPC, Interaction Study, Cycle Time Reduction, Value Stream Mapping, Mistake Proofing, Investigation and CAPA.

Professional Experience

Project/Process Engineer – Workhardt Laboratories, IL 2013 – Present

Observe Qualification projects then pinpoint, troubleshoot and resolve problems; implementing effective solutions.

Examine laboratory liquids’ batch studies to detect and resolve issues; recommending technical solutions for addressing parameters, tank and mixer optimization to improve processes affecting future scale-ups. Qualify and perform cleaning validation of process tanks.

Write, execute and enforce solid-dosage equipment qualification protocols. Play a key role in oral solid-dosage meetings and follow-ups to drive equipment qualification projects to obtain excellent end results.

Process Engineer – Nostrum Laboratories.MO 2011 – 2013

Headed technical support teams for process validation projects; directing/teaching team members and operators.

Continually collaborated with vendor audit team; providing critical input to optimize vendor selection process.

Conducted statistical analysis on oral solid-dosage products; executing improvement projects for every process step.

Educated validation technicians on writing and executing validation and qualification protocols.

Manufacturing Supervisor – Amneal Pharmaceuticals, NY 2009 – 2011

Oversaw approximately 40 operators and an associate supervisor in maintaining effective unit operations including dispensing, granulation, blending, compression, encapsulation and packaging.

Supervised manufacturing operations for approximately 30 pharmaceutical products and associated workforces.

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