Peter V. Email & Phone Number

San Diego, Ca, Us

San Diego, California, Us

San Diego, California, Us

San Diego, California, Us

Bubendorf, Ch

Costa Mesa, California, Us

Manager Facilities / Validations December 2008 - July 2014• Manage the validation, calibration, and facilities departments at Pyramid Laboratories facilities to support aseptic product manufacture. Authors procedures, protocols and validation reports for equipment calibration, maintenance, and environmental monitoring systems.• Completed the validation of major aseptic area manufacturing utilities including WFI, DI, Pure Steam, HVAC, CCA, Plant Steam, Chillers, Hot Water Boilers. Validates major manufacturing equipment such as, vial and syringe filling lines, autoclaves, lyophilizers, vial washer and depyrogenation tunnel.• Successfully represented Pyramid during multiple Quality System audits by customers and regulatory agencies including EU and FDA.• Set up and validated several IT systems to monitor and support environmental monitoring systems programs including Vaisala, Novatex, Climatec systems• Managed the validation of state-of-the-art 27,600 cubic feet storage warehouse that includes multiple temperature control units, labeling and packaging suites, back up power and security systems.

Saint-Quentin-Fallavier, Auvergne-Rhône-Alpes, Fr

• Managed the calibration and facilities departments for the San Diego SkyePharma facilities.• Managed facilities operations including (but not limited to): security, utilities, building maintenances, manufacturing equipment, clean rooms, filling lines, etc.• Primary company representative during FDA and EU regulatory inspections.• Managed the construction, commissioning, and validation of a new aseptic fill suite, which included refurbishing a Bosch integrated fill line capable of filling 20,000 vials in 8 hours.• Supported the day to day operations of manufacturing operations.• Developed employee career plans and yearly objectives, which included cross-functional training and technical skills enhancement which resulted in a highly motivated and customer service oriented group. • Implemented an equipment maintenance and calibration program to document equipment performance, maintenance, and traceability.• Developed a 5-year plan with cost analysis benefits for the replacement of manufacturing and facility equipment to increase reliability and support future manufacturing needs.• Improved equipment and building facility reliability from 45% downtime in 2004 to 5% downtime in 2007.• Managed 1.5 million dollar department budget.

Dublin, Oh, Us

• Managed the validation, calibration, and facilities departments.• Started-up and qualified the aseptic Manufacturing facility in a record six-month period, which included qualification of major facility systems (WFI, DI. Pure Steam, HVAC, etc) and a filling line. • Instrumental in obtaining a California FDB license to manufacture drugs within seven months after start-up.• Member of the leadership team that designed, built, and qualified a new sterile filling and lyophilization suite.• Responsible for writing, executing and maintaining the Validation Master Plan.• Used expert knowledge of GMP validation requirements, practices and standards to traine the facility team. • Oversaw vendors, maintenance and calibration contractors.• Supported GMP audits from customers and regulatory agencies. • Provided written responses to observations or findings related to the facility, validation or calibration programs.

Associate Director, Validation Services 2000 – 2002• Responsible for the management of all internal and external validation and calibration projects. (Annual budget of $400,000)• Principal contact for MCS audits, including customers and regulatory agencies.• Reviewed contract manufacturing (small volume parenteral contract manufacturer) projects to assure that they met Matrix validation requirements. (2001 contract revenue in excess of $2 million) • Oversaw internal and external process validations for Matrix Pharmaceutical, Inc.Manager, Validation Services 1997 – 2000• Authored the Validation Corporate SOP.• Wrote and maintained company Master Validation Plan.• Managed the validation of the start-up of the San Diego Manufacturing Facility, which included multiple contractors and a project scope of over $0.5 million.• Reviewed, coordinated, and developed all the validation and calibration templates for Matrix Pharmaceutical, Inc., including IQ, OQ, and Media Fill templates.• Trained San Diego personnel and contractors on validation procedures.Senior Manufacturing Engineer 1996 – 1997• Managed the product transfer of Matrix Pharmaceutical, Inc. between R&D and Manufacturing.