* ***** *****

Highland Mills, NY *****

Cell: 914-***-****

Voice: 845-***-****

Web Site: www.integratedinstrumentsolutions.com

E-Mail: ac6adi@r.postjobfree.com

John Musico

Instrumentation/Equipment/Product, Validation & Quality Assurance Engineer

Summary of qualifications

Over 30 year’s experience, including the following:

Instrumentation control system development and implementation. These include Process Control, PLC Programming, Water System, HVAC, Clean Room, Analytical/Process Instrumentation, Packaging Equipments, Waste Treatment, Sterilizer, Compress Air and Steam Turbine Combined/Cogeration.

Write and execute test scripts Installation Qualification, Operation Qualification and Performance Qualification (IQ/OQ/PQ).

Perform Factory Acceptance Test (FAT) and Site Acceptance Test (SAT).

Validation of Analytical/Process/Packaging Equipment, Compress Air, Clean Validation, Computers Software, HVAC/Clean Rooms, Aseptic Filling, Solid Dose, Product Process and Sterilization (Steam/Ethylene Oxide/Gamma).

Provide leadership and training in process validation, software validation, test method validation and data analysis.

Quality Assurance overseeing all FDA and ISO 13485 (Medical Device) compliance.

Perform instrument calibration per ISO/ANSI/NIST or any government regulation requirements.

Write all Standard Operation Procedure (SOP) used for Instrument Calibration, Maintenance, Packaging, Production, Process and Quality Assurance FDA/ISO.

Support all quality system activities leading to improve compliance with corporate policies, 21CFR820, ISO 9001, ISO 13485, ISO 14971, the Medical Device Directive, the Canadian Medical Regulation (CMDR) and other applicable regulatory agencies.

Insure that all projects are in compliance with GLP, QSR (including Design Controls), ISO or other applicable requirements.

Perform risk management assessment on all new and existing products.

Responsible for product packaging related to serialization and packaging 3D designed.

Education

New York State University Hartsdale, New York

Bachelor Degree in Electrical & Chemical Technology

DeVry Institute of Technology Woodbridge, New Jersey

Associates Degree in Electronic Technology

Professional experience

Professional experience (Cont’d)

Professional experience (Cont’d)

Professional experience (Cont’d)

Professional experience (Cont’d)

May 2018 – Present

Kolmar Laboratories Port Jervis, New York

Sr. Validation Engineering/Coordinator (Contract Work)

Write and execute test scripts (IQ/OQ/PQ) on new and existing product/packaging process.

Responsible for writing and review all SOP for new and existing product process.

Provides engineering support on new and existing product.

Perform risk management assessment on new and existing product.

Jul. 2017 – April 2018

Novo Nordisk Pharmaceuticals Lebanon, New Hampshire

Sr. Validation Engineering (10 Month Contract Work)

Write and execute test scripts (IQ/OQ/PQ) on new and existing process and analytical Equipment/Instruments.

Provides engineering support and trouble-shooting assistance for new and existing process Equipment/Instruments.

Perform Factory Acceptance Test (FAT) and Site Acceptance Test (SAT).

Perform risk management assessment on all new and existing process Equipment/Instruments.

Providing training to the operating personnel on the new and existing process equipment.

Served as a lead Project & Validation Engineer for the start-up and Commissioning of the new and existing process Equipment/Instruments.

Providing training to the Operating Personnel and Process Engineer on the new and existing Equipment/Instrument.

Responsible for writing and review all SOP for the new and existing process Equipment/Instrument.

Prepares engineering evaluations and test plants for and executes modification change control documentation.

Dec. 2016 – Jun. 2017

Mallinckrodt Pharmaceuticals Hobart, New York

Sr. Validation Engineering (7 Month Contract Work)

Write and execute test scripts (IQ/OQ/PQ) on 6 Packaging Lines.

Responsible for product packaging related to serialization and packaging 3D designed.

Provides engineering support and trouble-shooting assistance for new and existing packaging equipment.

Perform Factory Acceptance Test (FAT) and Site Acceptance Test (SAT).

Perform risk management assessment on all new packaging equipment.

Providing training to the operating personnel on the new and existing packaging equipment.

Served as a lead Project & Validation Engineer for the start-up and Commissioning of the packaging equipment.

Providing training to the Operating Personnel and Process Engineer on the Equipment/Instrument.

Responsible for writing all SOP for the new and existing Packaging Equipment/Instrument.

Prepares engineering evaluations and test plants for and executes modification change control documentation.

Dec. 2014 – Nov. 2016

Regeneron Pharmaceuticals Rensselaer, New York

Consultant (Engineering) (2 Years Contract Work)

Provides engineering support and trouble-shooting assistance for existing equipment and manufacturing processes.

Assists in design and specification on cGMP process equipment, piping, and/or controls.

Manages projects related to process equipment and manufacturing.

Assists in the design review, site acceptance and installation of equipment.

Prepares piping and instrumentation diagrams and other related drawings.

Supports Project Engineers through by preparation of design documents and assists in protocol execution.

Assists in investigations of process equipment/Instrument, utility systems, and control system anomalies.

Implements corrective/preventive actions for existing equipment and manufacturing processes.

Prepares engineering evaluations and test plants for and executes modification change control documentation.

Supervise mechanical, electrical, and automation contractors.

Maintains a clean and safe working environment by enforcing procedures, policies, and regulations.

Maintain company reputation by enforcing compliance with local, state, and federal regulations.

Served as a lead Project & Validation Engineer for the start-up and Commissioning of the Process Equipment/Instruments and HVAC systems.

Maintain the Calibration/Maintenance Blue Mountain data base.

Apr. 2014 – Nov. 2014

West-Ward Pharmaceuticals Eatontown, New Jersey

Sr. Validation Project Manager/Engineer (8 Month Contract Work)

Responsible for the validation of 20 HVAC Units. These units supply conditioned HEPA filtered air to Packaging Line and Clean Rooms.

Responsible for the validation of 3 Air Compressor Units. These units supply compress air to the utility system, research and production facilities.

Write and execute test scripts (IQ/OQ/PQ) on all HVAC units and air compress system.

Responsible for updating all design drawings.

Responsible for writing all SOP associated with all expect of the HVAC units and air compress system.

Provides engineering support and trouble-shooting assistance for existing equipment and manufacturing processes.

Responsible for the maintenance and calibration of the equipment.

Engineering Process/Design, managed all sub-contractors and internal maintenance personnel for the project.

Served as a lead Project & Validation Engineer for the start-up and Commissioning of the HVAC units and air compress system.

Providing training to the Operating Personnel and Process Engineer on the Equipment/Instrument.

Perform risk management assessment on all new process.

Implements corrective/preventive actions for existing equipment and manufacturing processes.

Dec. 2013 – Mar. 2014

Stryker Mahwah, New Jersey

Validation Project Manager/Engineer (4 Month Contract Work)

Responsible for the Engineering Process/Design, managed all sub-contractors and internal maintenance personnel for the LITH project.

Served as a lead Project & Validation Engineer for the start-up and Commissioning of the LITH process.

Write and execute test scripts (IQ/OQ/PQ) on the LITH Process and Packaging Equipment/Instrumentation.

Responsible for writing all SOP for the LITH process, new Packaging Equipment/Instrument associated with the new process to be incompliance with the FDA and ISO 13485 (Medical Device).

Responsible for the maintenance and calibration of the equipment.

Providing training to the Operating Personnel and Process Engineer on the new Equipment/Instrument and LITH process.

Perform risk management assessment on all new process.

Jul. 2013 – Nov. 2013

DePuy Synthes (Companies of Johnson & Johnson) West Chester, Pennsylvania

Validation Project Manager/Engineer (5 Month Contract Work)

Served as a lead Project & Validation Engineer for the start-up and Commissioning of Computer Numerical Controls (CNC) Process/Laboratory Equipment/Instrumentation and Packaging equipment.

Write and execute test scripts (IQ/OQ/PQ) on CNC, Process, Laboratory and Packaging Equipment/Instrumentation.

Responsible for writing all SOP for new and existing CNC, Process, Laboratory and Packaging Equipment/Instrumentation to be incompliance with the FDA and ISO 13485 (Medical Device).

Perform risk management assessment on all new and existing equipment and products.

Responsible for the maintenance and calibration of the equipment.

Providing training to the operating personnel on the new and existing equipment.

Jan. 2013 – Jun. 2013

GlaxoSmithKline East Durham, New York

Validation Project Manager/Engineer (6 Month Contract Work)

Served as a lead Project Engineer for the start-up Palletizer/Conveying system. This included the integration into the packaging lines, Spirals/Conveying and Robotic Palletizer.

Write and execute test scripts (IQ/OQ/PQ) on the Spirals/Conveying, Robotic Palletizer and Label Printer.

Responsible of the validation of the Spirals/Conveying, Robotic Palletizer and Label Printer.

Responsible for writing all SOP used for the new capital project.

Responsible for the maintenance and calibration of the equipment.

Perform risk management assessment on all new and existing products.

Responsible for product packaging related to serialization and packaging 3D designed.

Mar. 2012 – Dec. 2012

Zimmer TMT Parsippany, New Jersey

Validation Engineer/Project Engineer (10 Month Contract Work)

Responsible for the Chemical Vapor Depositions Reactors capital projects.

Responsible for the Engineering Process, managed all sub-contractors and internal maintenance personnel, IQ/OQ/PQ of the Chemical Vapor Deposition Reactors.

Responsible of the validation of the Chemical Vapor Deposition Reactors.

Responsible for writing all SOP used for the new capital project and existing Chemical Vapor Deposition Reactors to be incompliance with the FDA and ISO 13485 (Medical Device).

Perform risk management assessment on all new and existing products.

Responsible for the maintenance and calibration of the equipment.

Providing training to the operating personnel on the new Chemical Vapor Deposition Reactors.

Jan. 2006 – Feb. 2012

Advanced Biomaterial Systems Chatham, New Jersey

Validation Engineer/Project Engineer/Quality Assurance Manager

Responsible for all the validation of the equipment used for production and packaging.

Write and execute test scripts (IQ/OQ/PQ) on all equipment/instrument within the organization.

Responsible for FDA compliance.

Responsible for ISO 13485 (Medical Device) compliance.

Responsible for validation process of Steam/Ethylene Oxide/Gamma.

Prepares and manages regulatory submission (US/EU). Submissions include 510k.

Responsible for the maintenance and calibration of the equipment used for production, packaging and research.

Responsible for monitoring of clean room activity.

Responsible for engineering of new product and improving existing products.

Perform risk management assessment on all new and existing products.

Responsible for all production activity. These include aseptic filling, solid dose and assembly of delivery system (bone cement) used for implant surgery.

Manager of Quality Assurance.

Perform physical testing of product and package integrity per ISO standards.

Responsible for product packaging related to serialization and packaging 3D designed.

Responsible for all SOP used for production, packaging, research, FDA and ISO 13485 (Medical Device) compliance.

Jan. 2005 – Dec. 2006

WDF Inc. Mount Vernon, New York

Project Manager (12 Month Contract Work)

Managed capital project at the New York City Transit Metropolitan Transportation Authority (MTA). Supervise Installation of HVAC equipment and instrumentation; perform field service start-up, instrument installation and calibration for the all instrumentation. Write equipment start-up and instrument calibration procedure. Custom assembly of O & M Manuals.

Managed capital project at the New York City Department of Environment Protection (DEP). Supervise installation of HVAC instrumentation; oversee the installation, engineering and start-up calibration of all instruments. Write equipment start-up and instrument calibration procedure. Custom assembly of O & M Manuals. Review shop tested instrument panels.

Mar. 2003 – Present

Integrated Instrument Solutions Highland Mills, New York

Engineer, Consultant (Self Employed)

Write all SOP used for Instrument Calibration, Maintenance and Quality Assurance FDA/ISO.

Review all cGMP, ISO and FDA compliance.

Assists in design and specification on cGMP process equipment, piping, and/or controls.

Write Instrumentation and Mechanical preventive maintenance order.

Perform Instrument calibration and Mechanical preventive maintenance.

Perform risk management assessment on all new and existing products.

Supervise and perform field service and start-up for the equipment.

Perform validation all on start-up and existing equipment.

Responsible for product packaging related to serialization and packaging 3D designed.

Write and execute test scripts (IQ/OQ/PQ) on all equipment/instrument.

Responsible for engineering of new product and improving existing products.

Provides engineering support and trouble-shooting assistance for existing equipment and manufacturing processes.

Manages small-to-mid size projects related to process equipment and manufacturing.

Sep. 1980 – Feb. 2003

Wyeth Pharmaceuticals Pearl River, New York

Engineer/Maintenance Manager

Jan. 1993 – Feb. 2003

Managing 2 Instrument Supervisors and 3 Instrument Engineers.

Perform administrative duties.

Write standard operation procedures for all process and analytical Instruments.

Review all cGMP and FDA compliance.

Responsible for product packages related to serialization.

Review all preventive maintenance order.

Assist maintenance mechanics and supervisors in troubleshooting structural problems with shop personnel.

Review all out-sources preventive maintenance order.

Establishing instrumentation preventive maintenance order.

Served as a lead engineer for start-up of new projects and upgrades.

List of some of the projects work on: Water system, HVAC, Sterilizer, Batching tanks, Power distribution, Programmable controller and Environmental/Refrigerant Chamber.

Instrument Supervisor

Apr. 1987 – Dec. 1993

Perform administrative duties.

Responsible for work assignments of 14 Instrument Technicians.

Interface with vendors and sub-contractor for information in design efforts.

Coordinate engineering, service contractors, and trade union groups for the fabrication, installation, and start-up of instrument/control systems for the purpose of minimizing project costs and over-run.

Responsible for troubleshooting structural problems with shop personnel.

Write standard operation procedures for all process and analytical instruments.

Instrument Technician

Sep. 1980 – Mar. 1987

Responsibilities include installation of new instrument system.

Repair/Calibration of all process and analytical instrumentation for medical research, quality control, biological, and production.

Computer

Skills

Operating Systems: All Microsoft Windows.

Software: All Microsoft office (Word, Excel, Access Outlook, PowerPoint, Visio), Lotus Suit, Auto-Cad, Solid Work, Minitab, Blue Mountain, Maximo, Blue Beam and other programs similar to those. Able to utilize Internet resources to the fullest potential.

Reference

Available upon request.

Contact this candidate