SUMMARY:

• Extensive experience in process validations (IQs, OQs, PQs).
• Hands on experience wif in - process, supplier, cleaning nonconformance; providing immediate correction and bounding activities, identifying root cause and solving teh root cause wif appropriate corrective actions.
• Experience as a lead Manufacturing Engineer in support of teh transfer activities of a GMP Manufacturing facility, which include a Transfer Screw Vent (TSV) Implants, ZFX Dental and End of teh line (EOL) Product line.
• Expertise in using EtQ and TIPQA for Document Control and nonconformance processing respectively.
• Worked wif R&D and manufacturing on technical reviews, IQ/OQ and PQs of validation, test method validation.
• Well versed wif DFMEA, and PFMEA.
• Proficient in performing Test Method validation (TMV), Gage R&R studies, developing fixtures for manufacturing process.
• Detail oriented, highly motivated, and able to work independently or as a part of a team member.
• Hands on experience conducting Engineering studies for medical devices.
• Good experience wif 21 CFR Part 820, ISO 13485.
• Proficient in implementing Good Manufacturing Practices (GMP) principals, including validation,, document control, as well as Documentation Practices (GDP).
• Extensive experience in creating and updating of Standard Operating Procedures (SOPs).
• Knowledge of API (American Petroleum Institute) which we used in 620 & 650 low pressure tank.
• Follow OSHA (Occupational Safety and Health Administration).

TECHNICAL SKILLS:

Expertise: FDA 21 CFR Part 820 GMP, ISO 13485, ISO 9001, VMP (IQ, OQ, PQ S), TMV, BOM, SW, SOP s, DMR, PFMEA s, Routers, PVP, Software Validation, Proficient wif MS Excel, Word, Project, PowerPoint, Visio, Minitab, Visual Basic, Outlook, Adobe Acrobat, SolidWorks, API, ASME, PI&D, PFD, HYSYS, Drawing Viewer, EtQ, and TIPQA.

PROFESSIONAL EXPERIENCE:

Confidential, Palm Beach Gardens, FL

Manufacturing Engineer- Core

Responsibilities:

• Completed TSV Implant and ZFX Dental project as a lead Engineering.
• Currently supporting transfer of major product line’s final packaging as a lead Engineer.
• Created new BOMs, routers for all teh end-of-teh-line transfer process.
• Transferred fixtures related to all manufacturing process (cleaning, assembly components for implants, assembly components for packaging etc).
• Working on validation requirements (IQ/OQ/PQ), capability studies, Non-Standard material request, Pilot Builds, and other required documentations for teh transfer project.
• Wrote/revised/reviewed and reports.
• Created current and frozen costs for new resources for new standard operation code in Oracle.
• Coordinated wif multi-functional teams (product development, Quality, Manufacturing, Regulatory Affairs) to create to generate risk assessment documents (Process FMEA’s) for all teh manufacturing process.
• Created new visual instructions for all transferred manufacturing processes.
• Created drawings for manufacturing fixtures.
• Supported Packaging Area as a Manufacturing Engineer.
• Involved in daily activities including Equipment Validation, Cleaning Process validations, and writing temporary authority procedures for teh cleaning implants area.
• Participated in teh validation of teh vision system for detecting part mixes.
• Perform daily reviews of non-conforming work orders & scrap. This involves monitoring, investigating & correction of various manufacturing & quality related issues.
• Assist wif generation and maintenance of Standard Operating Procedures (SOP’s) and associated forms/ check list related to QC.
• Perform test method validations, Quality Tools, Gage R&R studies - Minitab.
• Assisted in updates of validation documentation (GxP risk assessment, verification and validation plan, test procedures and IQ/OQ protocol templates, etc.).
• Experienced in regulatory compliances, FDA guidelines and ISO standards in medical device industry (21 CFR820, ISO 13485).
• Perform monthly assessment on scrap & non-Conformance trends for each product family in manufacturing departments.

Confidential, Palm Beach Gardens, FL

Manufacturing Engineer - Remediation

Responsibilities:

• Performed GAP Analysis on Equipment Products and processes. Created a gap analysis spreadsheet collect all validation information and analyzed teh gaps and performed necessary remediation activities to address teh Gap identified.
• Core member of teh validation team, developing new organizational standards for validation protocols for products and process and manufacturing procedures. Performed Gap Analysis ensuring all validation and Regulation Compliance requirements are fulfilled, correctly and expeditiously.

Confidential, Freeport, TX

Process Engineer (Contractor)

Responsibilities:

• Dow Capital Project GMISS (Global Mechanical Integrity Safety Standards)
• Evaluated potential hazardous chemicals and over pressure scenarios and provided appropriate solutions.
• Applied ASME Section VIII Codes to protect pressure vessels and piping systems from over pressure. Applying API code to protect API 620 & 650 tanks from over pressure. Provided specs for relief devices like pressure safety valves (PSV), rupture discs (RD), and emergency relief vents (ERV) to processes to meet requirements by OSHA.
• Develop and technical drawings, P&ID’s, PFD’s, Prepare piping, equipment and instrument specification.
• Conducted field visits to verify data and information by meeting wif plant production engineers and run plant engineers.