SUMMARY:

• Operation Engineering Field Development, Troubleshooting, Pre - commissioning, Technical Analysis Commissioning, start-up, shutdown activities, EHS Audit, PFDs, P&IDs, CAPA,Minitab: Mean,Standard Deviation,Relative standard Deviation, Confidential, Cause and Effect Diagram(Fishbone or Ishikawa Diagram), Six Sigma(DMAIC),Root Cause Analysis,Design and Analysis of Experiments,VMware
• Updating SOP's and Control Specifications, TSCA, Best Practice, punch list, process upsets
• Perform laboratory tests to determine chemical and physical characteristics or composition of solid, liquid, or gaseous materials for such purposes as, process control, or product development by performing the ASTM Methods, Regulatory Compliance, QC/QA, Audits, Confidential, Confidential
• Support the review and management of product technical complaints and change control, Quality Management System including revision of SOPs,As well as review annual product reviews, review of batch records, maintain and utilize Quality Assurance databases, review documentation for compliance with cGMPs, FDA, ICH and other regulatory requirements and perform administrative tasks.

TECHNICAL SKILLS:

Software Skills: Bentley, TDMS, EDMS, ECM, SAP, LIMS, Matrikon, ASSAI, PDF Nitro, Lotus Notes, Microsoft Office, Lab View operating systems, Microsoft Visio, Adobe Acrobat

PROFESSIONAL EXPERIENCE:

Confidential

Operation Engineer

Responsibilities:

• Design control and working with Instron Tensile Tester with Blue hill 3.
• Working with electronic Quality databases/systems, Trackwise, SAP
• Reading and understanding Assembly drawings, manufacturing and test instructions, service manuals,
• Responsible for providing Quality oversight for 3rd Party Manufacturing to oversee activities of QA/QC and compliance functions to ensure compliance with cGMPs. ensure compliance and continuous improvement in quality functions
• Assist in product and prototype testing. Participate in Gage R&R studies.
• Document test results and communicate with R&D Engineers as required.
• Responsible for Careful, deliberate, disciplined, meticulous, and well organized in performing Laboratory testing and recording results.
• Follow Standard Operating Procedures, Good Documentation Practices.
• Medication & Procedural Solutions (M&PS) Research & Development, Advanced Product Development Services (APDS)
• Ensuring the safety, efficacy, purity, and quality of manufactured products through compliance with cGMPs, regulations and established procedures
• Play a critical role in supporting the group’s efforts with respect to medical device testing product for Design Verification and Shelf Life.
• Supports all product development and product engineering platforms across MPS, help the team by way of expertise and efficiency in a variety of mechanical, physical and electronic testing of medical device products, contribute to the improvement of existing testing methodologies, measurement system development & analysis of test methods.
• Responsible for the testing performed will help ensure that products meet customer’s expectations and regulatory requirements, disciplined product development processes, regulatory, quality requirements and design controls, such as 21 CFR 820.30
• Perform the job using appropriate Personal Protective Equipment, follows Standard Operation Procedures, Good Laboratories Practices and Good Documentation Practices.
• Test performed by following test protocol or test instruction written by Engineer & also Test consists cleaning a medical device using different disinfecting wipes will be used to evaluate and determine performance after completing the required disinfecting cleaning cycles.
• A functional verification will be performed connecting the device to established communication with software
• Knowledge on testing software, firmware and hardware by following test protocols

Confidential

Laboratory Inspector

Responsibilities:

• Operates laboratory equipment and instruments such as microscopes, centrifuge, agitators, viscometer, chemical balance scales, spectrophotometer, gas chromatograph, colorimeter, and other equipment.
• Test materials for presence and content of elements or substances such as hydrocarbons by ASTM methods,
• Test samples of manufactured products to verify conformity to specifications and Records test results on standardized forms and writes test reports describing procedures use.
• Prepares graphs and charts and calibrates laboratory instruments
• Support the management of complaints, deviations, change controls, non-conformities etc.

Researcher and Engineer

Confidential

Responsibilities:

• Follow Confidential of Classification and Labeling Chemicals, SDS and EHS Label creation, near misses
• As per Confidential Regulation updated data in Share Point for the new chemicals SDS, order shipment review and release, compliance with all federal, state and local regulations, implements policies and procedures, knowledge of EPA and DEA Calibration of analytical instruments
• Perform tests such as density, pour point, cloud point, and GC, HPLC, Sulfur, Viscosity, Flash Point, TDS, TSS, Conductivity, pH as per FDA regulation for QA, QC, GMP, R&D and pilot plant programs
• Review validation protocols, Master Documents etc.

Operation Engineer

Confidential

Responsibilities:

• Familiarity with ASME, API, and NFPA, IDLH, SCBA, NIOSH, FEED,EPIC,FS, SOW,SOR,PCR, MCC, TOC,ACC, Fire, safety, ISO 9001, ISO 14001, confined space permit, Hot /Cold work permit
• Used Maximo and continuous improve equipment preventative and corrective maintenance
• SOR Evaluation, recommendation & final approval as a Focal Point
• Participate for process related matters Reviewing PCR for approval / rejection and carrying out PCR detail engineering and making it ready for implementation.
• Review & approve all permanent process & trip setting change requests to meet operation requirements, review & update documentation and drawing on periodical basis
• Support the development and negotiation of Quality Agreements Compile and report KPIs
• Successfully trained Qatari Trainee for the profile of senior process technician and provided them guidance and assistance

Confidential

Responsibilities:

• Hazard identification & Risk Assessment before doing the job, strict control of unsafe conditions and unsafe acts, Quality Management System, ISO Management, excellent understanding of LEAN and Six Sigma principles, EPIC, Project Management, scheduling and TA Planning, COS Removal
• Fall Protection, Provides Safety Hazard input to HAZOP, HAZID studies, excellent project coordination and execution skills, written PPE program and Confidential regulations, Technical Writing