Project Manager Management

Russell Regan **.*****@*******.*** 315-***-****

PROFESSIONAL QUALIFICATIONS

A highly motivated, project-oriented individual seeking to be a team player with a growth-oriented company. Over

twenty years of commissioning, qualification, verification and validation experience in the pharmaceutical,

biotechnology, cosmetic and medical device industries, working for various companies. Computerized Systems

Validation (CSV) Subject Matter Expert (SME).

PROFESSIONAL EXPERIENCE

Experience and areas of expertise include, but are not limited to:

• Commissioning, Configuration, Qualification, Verification and Validation of pharmaceutical equipment,

instruments & systems, including ERP, MES, CMMS, DCS, BMS, SCADA, PLC and HVAC in a cGMP

environment utilizing the Good Automated Manufacturing Practices (GAMP) life cycle methodology, ISPE

Baseline Guides, ASTM E2500 Guide, and ICH Q9 and Q10. Computerized Systems Validation (CSV) Subject

Matter Expert (SME). Quality oversight of CFR Parts 820, 11 and Annex 13

• QA/QC equipment/systems, troubleshooting, resolution of problems, process improvements.

• Experienced in writing, executing, and reviewing validation master plans, project plans, vendor audits, user

requirements specifications, risk assessments, functional specifications, detailed design specifications, factory

acceptance tests, site acceptance tests, installation qualification protocols, operational qualification protocols, pre-

functional checks, functional checks, final reports, standard operating procedures and work instructions.

• Project management, development and monitoring of project scope, budget, and schedule. Coordinated

resolution of problems, deviations, exceptions and issues including Change Control.

• Contributed to successful implementation and support of regulatory compliant control solutions including

commissioning and startup, qualification and validation on many projects in USA & overseas.

Career skills include, but are not limited to:

• Liaison with manufacturers, vendors, contractors, quality, engineering, validation and clients.

• Project management, supervision of contractors, engineers and software developers.

EMPLOYMENT:

2004 – Present RJR Technical Services, Rome, NY

Integrated Commissioning & Qualification Project Manager

• Managed various projects around the world and was responsible for GAMP document

deliverables (Risk Assessment, VMP, QAP, URS, FS, DDS, FAT, SAT, IQ, OQ, Traceability Matrix, SOP, and

summary reports) and protocol execution to each client utilizing ISPE Baseline Guides, ASTM E2500 Guide, and

ICH Q9 and Q10.

• Quality Engineer to review commissioning and qualification documentation including DeltaV

DCS and Syncade MES Recipe Validation. In-depth use of the recipe authoring tool to verify configuration of

class-based designed manufacturing recipes.

• Computerized Systems Validation (CSV) Subject Matter Expert (SME).

• Validation Project Manager to perform quality control and review of GAMP documentation.

• Quality system assessment of all automation documentation for corporate Quality System

Improvement Program.

• Software Quality Analyst on a Medical Device production line.

• Interacted with clients and engineers to solve hardware, software, process and documentation

problems.

• Quality Engineering Subject Matter Expert (SME) for FDA Pre Approval Inspection (PAI)

2003 – 2004 Invensys Validation Technologies, Foxboro, MA

Senior Project Manager

• Managed various projects around the world and was responsible for GAMP document deliverables and

protocol execution to each client utilizing the ISPE Baseline Guides, ASTM E2500 Guide, and ICH Q9 and Q10.

• Coordinated engineering, operations, quality and third party groups. Performed quality control and review

of GAMP documentation.

• Responsible for training the project teams on cGMP’s, GAMP, qualified commissioning and IVT

Validation methodology.

• Provided sales support on Validation, Regulatory Compliance and Project Management and quote

generation.

Developed training modules for IVT in house use.

Russell Regan

2001 – 2003 Invensys Energy Solutions, Rockford, IL

Director of Operations, Invensys Pharmaceutical Environments

• Responsible for Validation, Regulatory Compliance and Project Management for the SIGMA BAS/BMS system

• Responsible for the Quality Management System and complete life cycle approach of the software development.

• Managed Invensys BAS/BMS projects around the world and was responsible for GAMP document deliverables to each

client utilizing the ISPE Baseline Guide Commissioning and Qualification and GAMP.

• Computerized Systems Validation (CSV) Subject Matter Expert (SME).

• Responsible for training the project teams on cGMP’s, GAMP, Project Management, qualified commissioning and

IVT Validation methodology. Developed training presentations for this.

• Provided sales support on Validation, Regulatory Compliance and Project Management and quote generation.

Developed presentations and databases to support this.

• Responsible for conducting any quality audits of Invensys required by each client. Passed corporate global quality

audits from five major pharmaceutical clients which led to global corporate purchasing agreements.

1998 – 2001 Invensys Validation Technologies, King of Prussia, PA

Validation Specialist, Project Manager, Director of Operations, USA

• Responsible for Validation, Regulatory Compliance and Project Management for the US. Managed multiple project

managers at various client sites. Responsible for all deliverables to the clients. Projects included DCS, SCADA, PLC, HMI,

LIMS, WMS, Refrigerated Warehouses, HVAC, BMS, Utilities, stand alone or skid mounted equipment such as Washers,

Autoclaves, Fillers, WFI Stills, Steam Generators, Freezers, Depyrogenation Ovens, Cappers, Labelers, Vision Inspection, CIP,

SIP, Cartoner, Inserter, and Checkweigher.

• Computerized Systems Validation (CSV) Subject Matter Expert (SME).

• Managed various validation projects for various clients and was responsible for GAMP document deliverables to each

client.

• Responsible for training the various project teams on cGMP’s, GAMP, and IVT Validation methodology.

• Responsible for the US business unit to manage the operations, review requests, write proposals and develop new

business. Managed US back office affairs such as HR, accounting, marketing and benefits.

• Acquired extensive knowledge of GAMP

• Responsible for conducting any audits of Invensys required by each client.

• Acquired extensive knowledge of current Good Manufacturing Practices.

• Interacted with client and software developers to solve documentation and software problems.

• Managed project schedule aspect of projects for clients.

1997 – 1998 RJR Technical Services, Havertown, PA

Consultant

1995 – 1997 Steripharm Technologies, Havertown, PA

Technical Service Manager

1994 – 1995 American Technical Services, Malvern, PA

Senior Field Service Specialist

1992 – 1994 AMSCO Scientific, Erie, PA

Senior Bio-Pharmaceutical Field Service Specialist

• Responsible as the Manufacturer’s Representative for FAT, installation, commissioning, SAT and service of Amsco,

Stilmas, Fedegari and Finn Aqua Autoclaves, Pure Water Stills, and Pure Steam Generators for North and South America.

Provided validation support and training to clients for this equipment.

• Managed various projects for various clients and was responsible for installation, commissioning, cycle development,

validation, and regulatory compliance of these projects for each client.

1983 – 1990 United States Navy, Electricians Mate First Class, Submarine Service

• Electrician’s Mate “A” school

• Navy Nuclear Power School

1.

PROFESSIONAL AFFILIATIONS

• Member of International Society of Pharmaceutical Engineers (ISPE)

• Member of GAMP Americas Forum and JETT SIG

• Member of The Instrumentation, Systems and Automation Society (ISA)

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