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Engineer Validation

Location:
Waymart, Pennsylvania, 18472, United States
Posted:
January 07, 2018

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Resume:

*** ******* *****

Waymart, PA *****

Phone 570-***-****

P/E: ac3x13@r.postjobfree.com

QUALIFICATIONS

Over twenty-five (25) years of progressive experience in the Biopharmaceutical, Pharmaceutical (device and drug) and Cosmetics industries with familiarity in up to date cGMP’s, Quality, and Regulatory guidelines. Current membership with PDA and ASQ.

Very flexible with the ability to work on projects with little or no supervision, yet consistently meet timelines on or before schedule.

Prepare and execute protocols, revalidation test plans, and summary reports for equipment validation, cleaning validation, process validation, as well as support document and equipment change requests relating to validated systems and impact to the clean state at Bulk Manufacturing and Fill/Finish facilities.

Knowledgeable on Validation of Equipment, Utility, Process Validation, Cleaning Validation (CIP, COP, Manual Cleaning), SIP, and applicable Change Control for these activities.

Risk Assessment lead and Validation SME to assess risk for systems and equipment.

Wide exposure to utility systems and process equipment, validation principles, and concepts associated with existing facilities and start-up of brand new facilities.

Able to solve mechanical, procedural, and operational discrepancies.

Highly motivated individual with the ability to get along with others in and around the organization to promote team building and team cohesiveness.

EDUCATION

University of Phoenix

Masters in Business Administration – Technology Management, 2014

Major: Technology Management

Delta Mu Delta Member (International Honor Society for Business)

Bachelors of Sciences with honors, 2010

Major: Business Management

Orange County Community College, Middletown, NY

Associates Degree in Applied Sciences, 1994

Major: Business Management

PROFESSIONAL EXPERIENCE

Director of Regulatory/Validation Process Technologies & Packaging, LLC – Olyphant, PA

JUNE12 – JAN18

Promoted to Director of Regulatory/Validation (May 2013); previously Validation Manager.

Oversaw the regulatory requirements for Cosmetics and Over-The-Counter Drugs (Powders, Creams, and Lotions). Responsible for ensuring compliance with state, federal, and international regulations (FDA & EU Compliance).

Ensured Cosmetics and Over-The-Counter Drugs site registrations are up to date and acted as a liaison during FDA inspections.

Implemented and oversaw the Validation program for Over-The-Counter Cosmetics/Drugs manufacturing facilities (Powders, Creams, and Lotions). This includes Equipment, Utility, Cleaning, and Process Validation.

Examples of equipment are Pulverizers, Ribbon Blenders, Cappers, Fillers, Homogenizers, Mixing Tanks, etc.

Developed and maintained Validation Master Plans for the company. This included Site Validation Master Plan and Cleaning Validation Master Plan.

Implemented and oversaw the Change Control program for Validation equipment that was qualified. This included creating of Access Database to track the Change Control program.

Created new SOPs for the Validation, Maintenance, Calibration, and support programs. This also included revision of current SOPs to be compliant to cGMP standards.

Oversaw the Calibration program as it related to vendor calibration.

Worked with Engineering and Facilities to develop process flow maps and facility drawings.

Validation Engineer/Associate Validation Engineer – Validation Department Genentech, Inc. - Vacaville, CA

APR05 – JUNE12

Promoted to Validation Engineer (April 2009); previously Associate Validation Engineer

Front Line Support of Upstream Cell Culture operations pertaining to Validation and cross-trained into Manufacturing Sciences functions.

Risk Session lead (Validation SME) for equipment to assess risk for legacy systems (PHA, Harm Matrix, etc.).

Protocol generation, field execution and report review for equipment and cleaning validation for Fill/Finish equipment.

Prepared and executed protocols, revalidation test plans, and summary reports for validations of equipment, utility systems, cleaning validation (CIP/COP/Manual, Washers, Visual Inspection w/HD Camera) and SIP of tanks.

Change Control and Discrepancy reviewer/approver for changes/discrepancies to validated systems using Trackwise system.

Co-developed QA Real Time Review of Validation testing to reduce summary report cycle times from an average of 90+ days to less than 30 days.

Developed TC/BI Placement Technical Report to provide rationale for placement of TC/BIs in equipment as a response to FDA Observation.

Class A Leader for the Validation Department to obtain certification for world-class organizations via Oliver White (People, Process & Technology for Planned, Predictable Performance).

Reviewed protocols, reports, and data tables generated by peers and contract personnel.

Supported document and equipment change requests relating to validated systems.

Interacted routinely with Quality, Manufacturing, Engineering, Facilities, as well as Planning and Scheduling for validation executions.

Validation SME and Project Manager for Increased Run Rate projects, Plant Shutdowns and Product Campaign Changeovers for multi-product World Class facility producing Rituxan, Avastin, Herceptin, Xolair, etc..

Performed Gap Assessment and Remediation Planning for Validation and Quality Systems.

Supported Inspection Management Department in Regulatory Agency Inspections and Internal Partner Audits.

Quality Engineering Assoc. III & QA Validation Assoc. II– Quality Department

Biogen Idec, Inc. (formally IDEC Pharmaceuticals) - San Diego & Oceanside, CA

JUL02 – APR05

Promoted to QE Associate III (Sep 2003); previously QA Validation Associate II

Developed Validation Master Plans and Summary Reports for Rituxan, Zevalin Kit Components, IDEC-159 (Phase I) process. Also provided validation oversight for the IDEC-114, IDEC-159, and Zevalin Kit Component product campaigns.

Participated in successful agency inspections by the FDA and EMEA in 2003, 2004, & 2005. No major 483’s were given in 2003 and no 483’s in 2004 or 2005.

Successfully closed out Equipment/Facility Change Requests (EFCR) from 102 to 0 in an 8-month span. The EFCR program was archived and rolled into the Change Control Program.

Developed shutdown procedures to streamline the process of starting up a facility after preventive maintenance shutdown of manufacturing areas. Successfully used the procedures without any deviations/discrepancies and reduced shutdown time significantly.

Archived all SOPs that pertained to EFCR and Decommissioning prior to being rolled into the Change Control System.

Reviewed validation protocols such as I/OQ & PQ protocols for Process Validation, Utility, HVAC, WFI, RO, Clean Steam, Environmental Monitoring, Column Chromatography, some Computerized Systems, CIP/SIP, and Environmental Chambers in Purification and Cell Culture environments. Generate Validation Master Plans and Reports for Facility and Processes/Equipment. Evaluate the current validated status of all utility, facility, process, critical equipment and computer systems.

Reviewed the associated protocols and Validation Evaluation Reports for each system evaluated on a quarterly basis. Make suggestions for improvements as well as ensure the system, utility and critical equipment is operating in compliance and in a validated state.

Evaluated EFCRs and Maintenance Work Requests specifically for impact to validated systems. Evaluated and summarized each on an annual basis for an Annual Product Report, which was submitted to the FDA. Managed and tracked Change Control system through in-house databases.

Validation Specialist & Technician – Quality/QA Dept. Alliance Pharmaceutical Corp. San Diego, CA

FEB00 – JUL02

Promoted to Validation Specialist (Sep 2002); Previously Validation Technician

Participated with the Validation Dept in two (2) FDA PAI's, the last one resulting in no 483’s. Performed two (2) FAT’s for new equipment at the manufacturer’s site.

Executed Process Validations and Cleaning Validations for single-product facilities (2).

Wrote and routed all validation protocols (IQ, OQ, PQ, Change Control), executed the protocols, and wrote the final reports for finished validation tasks on systems/equipment. The systems included Lab Line Environmental Chambers, Kuhlman Steam Sterilizers, Getinge Sterilizers, Puffer Hubbard Freezers, Precision Refrigerators, Autoclaves, Videojets, Vacuum Systems, Travaini Vacuum Pumps, Compressed Air System and Kobelco Air Compressor with Allen Bradley PLC controls, Fillers, Russell Finex Sieve and Blend machines, Formulation Tanks, DCI Stopper Washers, Spray Dry equipment, HVAC Systems, WFI Systems, Clean Steam Systems, Purified Water Systems, Nitrogen and High Pressure Nitrogen Systems, ChemServer/Printers, Calibration Management Systems, and Building Management Systems

Manufacturing/Calibration/Validation Technician Alliance Pharmaceutical Corp. Otisville, NY

AUG91 - FEB00

Manufactured drug and device products

Assisted Validation Dept in performing Process Validation for the LiquiVent process.

Worked with Engineering and QC Depts. to help identify critical process parameters, sampling plans, in-process controls, and final product testing for drug process.

Performed Validations/Revalidations on manufacturing equipment such as Blue M Dry Heat Ovens, Fillers, Cappers, and Labelers

Performed Validations/Revalidations on QC equipment such as Getinge Autoclaves and Lab Line, Thermolyne, and VWR Incubators/Environmental Chambers, Freezers, and Refrigerators

Performed Validation activities on Compressed Air, Vacuum, Nitrogen and Purified Water Systems

Managed Calibration Program using Blue Mountain Calibration Software and Calibrated in house equipment

Trained in various QC sampling activities, including receipt of and sampling of raw materials as well as Microbiology testing of Purified Water System and BI Strips.

Performed Shipping and Receiving duties on an as needed basis

ADDITIONAL SKILLS/ACCOMPLISHMENTS

Cleaning Validation Swab technique qualified

Class 100 Gowning Qualified in Aseptic Techniques

Advanced knowledge in MS Windows (up to Win7), Apple OSX, MS Office (Win and Mac), MS Access, MS Visio and Lotus Notes Database.

Advanced knowledge in Kaye Validation Software and Programming of Kaye Validation equipment (Val 2K, ValProbes, Digistrip 4S+, Portable), Fluke Multimeters, Digital Hygrometers, Cox Tracers, Allen Bradley PLCs (Programmable Logic Code)

Above average knowledge of TrackWise, SAP, general computer programming, and hardware installation

Intermediate knowledge in Documentum, Document Control, Electronic Document Management System (EDMS), eDocS electronic document routing system (Power User level access) and ISO Train On-Line Training Software

1993 – “On-Belay” Award for Sat Pad Device Team Co-Leader

1995 – “Quick-Draw” Award for importance to the success of the company

2005 – 2010 – “GenenChecks” Awarded ten (10) times for going above and beyond job function for the company and living the Corporate Core Competencies.

2007 – “Key Contributor Bonus” Awarded annually to only 8% of all employees for key asset to the company.

ADDITIONAL TRAINING

Annual PDA/FDA Joint Conference/Quality by Design for Biopharmaceuticals: Concepts and Implementation (4 day Conference/Seminar), Washington, DC

Process Validation Techniques and Industry Trends (3 day seminar), PDA - Boston, MA

Recovery and Purification of Biopharmaceuticals (3 day course), Center for Continuous Education - San Diego, CA

Biopharmaceutical Production Technology (4 day course), Center for Continuous Education - San Diego, CA

Cleaning Validation and Cleaning Techniques (2 day course), STERIS Corporation - San Diego, CA

Cleaning Validation and Clean Room Controls (2 day course), Orange County Regulatory Affairs (OCRA) - Costa Mesa, CA

Pharmaceutical Water Systems (2-day seminar), Center for Continuous Education - Irvine, CA

Kaye Digistrip 4 Plus & Validator Training (5-Day course), Kaye Instruments - Chelmsford, MA

Professional and personal references are available upon request



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