Project Manager Design

Louis Isernia

** ********* ***** 215-***-**** (Home)

Doylestown, PA 18910 610-***-**** (Cell)

PROGRAM MANAGER ENGINEERING

Summary Statement: Extensive experience in Biotech/Vaccine facility design and construction. Specializing in design, construction, commissioning and start-up of Pharmaceutical Development Lab’s, API/Formulation facilities, Aseptic filling (syringes/vials) and packaging processes, clean process utilities. Highly versed in aseptic manufacturing and knowledgeable of cGMP’s. Known for a creative approach to problem solving, strong collaboration with project teams and establishing outstanding relationships with colleagues.

PROFESSIONAL EXPERIENCE

PFIZER, Collegeville, Pennsylvania 2009-2010

PGE Engineering Site Lead

Lead all engineering activities and support Pearl River site for all Capital Projects >$500k, Facility Renovations, Global Reliability Program, Energy Conservation Initiatives, Integrated Facilities Management (IFM), Maintenance Stores (MRO), CIG’s.

WYETH, Collegeville, Pennsylvania 2001-2009

Engineering Project Manager

Manage design teams of engineering consultants on the design, construction and commissioning and start-up of Biotech facilities.

• Managed design & construction teams on $16.5MM Vaccine Manufacturing facility expansion in Pearl River, NY

• Managed design & construction teams on $40MM Protein/Vaccine development facility in Dublin, Ireland

• Managed design & construction teams on $90MM Isolator syringe filling project in Dublin, Ireland

• Managed design teams on $225MM Solid Dosage facility in Dublin, Ireland

• Managed design & construction teams on $300MM Drug Product facility in Dublin, Ireland

• Manage FAT teams on all process and utility equipment associated with projects

• Manage capital budgets and review cost reporting associated with each project

• Interact with manufacturing leads, Validation/Tech. Services, QA/QC and site engineering as required

DAY & ZIMMERMANN, Philadelphia, PA 2000-2001

Director of Biotech Fill/Finish Facilities Design

Manage process engineers on all activities pertaining to the design of fill finish facilities

• Lead conceptual and preliminary design teams on all Fill/Finish projects

• Prepare departmental expense budgets

• Prepare project proposals

• Perform business development activities

• Lead audits of in-house project designs

RAYTHEON ENGINEERS & CONSTRUCTORS, Philadelphia, PA 1995-2000

Manager of Biotech Fill/Finish Facilities Design

Manage process engineering teams and develop design documentation for various types of Biotech manufacturing facilities and equipment.

• Manage technical SME’s in the design of biotech manufacturing facilities.

• Design and implement filling and packaging equipment used to process syringes, vials, bags, droppers, tablets, tubes.

• Design and implement GMP process utility equipment.

• Prepare equipment specifications, equipment selection, evaluation, audits, procurement, expediting, FAT, installation, validation, training, SOP’s, PMO’s and startup.

• Oversee facility upgrades, expansions and renovations for process improvements and compliance to cGMP’s.

WYETH-LEDERLE VACCINES & PEDIATRICS, Pearl River, NY 1981 – 1995

Validation Group Leader

Managed validation specialists on various projects within the biological sterile filling and packaging department.

• Performed protocol report preparation and submission for approvals.

• Performed validation of vaccine manufacturing processes, process equipment, and facilities (HVAC).

• Developed Validation Master Plan for Parenteral Manufacturing department.

• Established revalidation and change control program.

• Validated irradiation process for diagnostic devices.

• Managed revalidation effort of sterile filling facility after completion of major renovation.

• Validated filling and packaging equipment and support equipment.

Engineering Project Manager

Managed the activities of major capital projects greater than M$1.0 for the biological vaccine division.

• Performed engineering feasibility study to construct Biotech Manufacturing facility in Catania, Italy. TIC $80M

Project Engineer

Prepared capital project justification reports and performed new equipment specification and design including overall responsibility for installation, validation (IQ, OQ), startup and training.

• Defined, established and maintained critical spare parts inventory for major pieces of equipment.

• Established PMO database and scheduled preventative maintenance for all process and utility equipment and ensured proper recording and documentation.

• Provided direct support to all Biotech filling and packaging areas for support and resolution of equipment breakdowns, production delays and quality/GMP issues.

Validation Specialist

Designed, planned, coordinated and performed validation projects in various parenteral manufacturing departments.

• Collected, summarized and evaluated validation data for preparing validation documentation (protocols).

• Used validation equipment and instrumentation to perform studies and evaluation of facility operation and performance and process equipment and systems.

• Interacted with manufacturing, safety and loss prevention, purchasing and engineering to achieve validation master plan objectives.

• Validated: Ethylene Oxide sterilizers, steam sterilizers, dry heat ovens, glassware washers,

depyrogenation tunnels, sterile environments, various types of filling machines, packaging lines, labelers, bar-code scanning devices, etc.

PROFESSIONAL DEVELOPMENT

Capital Project Management Process – Core Team Member

Capital Project Management Process Community of Practice (CoP) – Leader

S.H. Darrow Leadership Development

Drexel University Project Management Development Program

Red Belt Certified

EDUCATION

Bachelors in Electrical Engineering Technology - Fairleigh Dickinson University

Masters in Engineering Management – Drexel University

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