Project Manager Engineer

QA Compliance, Computer and Equipment Validation Manager with 15 years experience in FDA regulated environments. Agile, results oriented leader with strong communication, and organizational skills.

SUMMARY:

● Full Validation life cycle experience including developing and maintaining Validation Plans/Policies, Formal Risk Assessments, Validation Project Plans, Specifications, Design Review, Commissioning Documentation, SOPs, Validation Scripts, preparing Validation Reports and implementing Change Control within the GxP environment.

● Main area of expertise, Compliance, Computer Validation, Equipment Validation, and Environmental Monitoring, QA Audit and working knowledge of Cleaning Validation, Technology Transfer and Process Validation (solid dosage and sterile environments).

● Strategic implementation and alignment expert with over 15 years experience in managing personnel and capital projects (project management experience).

● Track record for providing definitive compliance and technical expertise for Manufacturing, Lab and Quality software, hardware and instrument related projects including 21CFR Part 11, Part 58, Part 210, and Part 211.

● Subject matter expert – US 21 CFR Part 11.

● Experienced as Team Lead, Project Manager, Supervision, team resource and individual contributor

ACHIEVEMENTS:

● Saved $700K while managing a capital project obtained via merger and acquisition synergy.

● Successfully developed a computer validation department for a well know pharmaceutical manufacturing firm that included managing personnel and authoring/implementing new procedures/policies.

● Computer validation project manager for a new $52 million pilot plant for a major biopharmaceutical manufacturer.

EDUCATION:

University Of Kansas, Lawrence, Kansas

Kansas State University, Manhattan, Kansas

Bachelor of Science, 1981

University of Phoenix, Phoenix, Arizona

Masters of Business Administration, 2009

SKILLS:

Life Sciences: FDA Quality System Regulation, IQ/OQ/PQ, FDA Compliance, GxP (GCP, GMP, GLP, GDP) GxP Audits, Change Control, Building Automation Systems, SAP, HP Quality Center, Documentum, eInfoTree, 21 CFR Part 11, LIMS, HPLC, Bar-code Systems, Vision Systems, Aseptic Fill and Aseptic Environments, Kitting Line Robotics, PLCs, SLCs, SCADA, Ladder Logic, Wonderware, DCS (Distributed Control Systems), DDC (Direct Digital Control Systems), CIP & SIPs, Purification and Ultra-Filtration, Bioreactors, Fermentors, Lyophilizers, Stills, Autoclaves, Clean Steam, Water for Injection, Biowaste deactivation

Environments: Client-Server, PC (NT, 2000, XP, Vista, Windows 7), Unix, MFCS WIN, Unicorn, Data Highway +, Ethernet

Applications: Expert: MS Project, AutoCAD 2000, MS Word, MS Excel, Visio, HP Test Director. Excellent writing ability, strong problem solving skills, interpersonal communication, and experience with team building.

EXPERIENCE:

Pfizer, Inc. (King Pharmaceuticals, Inc. prior to Pfizer M&A) 8/2004 - Present

Manager of Compliance responsible for the implementation, design, administration, coordination, documentation and performance of utility, automation and computer system validation activities along with managing two direct reports. Projects since hire include Purified Water System and its controls, Building Management System, SAP Validation, Network Qualification, Documentum Document Management System, HP Quality Center, eInfoTree, Sales Force Automation software and hardware conforming to PDMA regulations, Liquent InSight FDA Electronic Publishing System, Argus Drug Safety system, StarLIMS, and Empower Chromatography Data System. Sponsored and wrote corporate policies for Network Qualification and CFR 21 Part 11 and departmental policy for Computer Systems Validation including Software Development Lifecycle documentation.

CGMP Validation LLC (Validation Consultants) 6/1997 – 8/2004

Validation Engineer (11 years) responsible for the implementation, design, administration, coordination, documentation and performance of equipment, utility, automation and computer system qualifications.

Clients Include:

● IVAX Research, Inc., Garden Glades, Florida

● Wyeth Pharmaceuticals, Richmond, Virginia

● Amgen, Providence, Rhode Island

● Avecia Biotechnology, Inc., Milford, Massachusetts

● Pharmacia (now Pfizer), Chesterfield, Missouri

● Aventis Behring, Kankakee, Illinois

● Bayer, Shawnee, Kansas

● Alcon Laboratories, Inc., Fort Worth, Texas

● Wyeth-Ayerst Laboratories, Inc., Marietta, Pennsylvania

CRB Engineers, Inc. (Consulting Engineers) 5/1994 – 6/1997

Engineering Project Manager

HVAC Engineer and project manager for major pharmaceutical projects, HVAC and Building Management.

Integrated Health Services (National Healthcare Organization) 4/1990 – 5/1994

Director of Engineering

Director of Engineering for a national sub-acute health care company. Directed, coordinated and exercised functional authority for planning, organization, control and completion of more than 20 construction project per year.

Peters-Eichler, Inc. (Mechanical Contractors) 6/1986 – 4/1990

Design Engineer/Construction Project Manager

Haberberger Design, Inc. (Consulting Engineers/Construction Managers) 6/1984 – 6/1986

Design Engineer/Construction Project Manager

Harley Gordon & Associates, Inc. (Consulting Engineers) 6/1981 – 6/1984

Project Engineer/Designer

Contact this candidate