Peter V. Email and Phone Number
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Enthusiastic and dynamic operations professional with over 30 years of extensive experience in the Biopharma / Pharmaceutical and in vitro diagnostic industries. Broad range of responsibilities included operational oversight of sterile manufacturing facilities including validation, calibration, facility management, process development, technology transfer and project management functions. Industry expert in quality control testing, environmental monitoring systems and formulation development. Possesses comprehensive and current understanding of technical, compliance and regulatory requirements for domestic and international registrations including expert knowledge of cGMP and ISO requirements. Created, recruited, trained and led highly motivated staff to carry out complex manufacturing and validation functional activities. Drafted and managed multi million dollar department budgets. Specialties: Director of Validation, Calibration, and Facilities Departments
Trilink Biotechnologies, Part Of Maravai Lifesciences
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Director Of ValidationTrilink Biotechnologies, Part Of Maravai Lifesciences Sep 2022 - PresentSan Diego, California, Us
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Associate Director Of ValidationTrilink Biotechnologies, Part Of Maravai Lifesciences Apr 2020 - Sep 2022San Diego, California, Us
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Senior Quality Engineer, ValidationTrilink Biotechnologies, Part Of Maravai Lifesciences Dec 2018 - Sep 2022San Diego, California, Us
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Qa Validation ManagerBachem Sep 2017 - Nov 2018Bubendorf, Ch -
Director Qa/Facilities / ValidationsPyramid Laboratories Inc. Dec 2008 - Sep 2017Costa Mesa, California, UsManager 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. -
Director Plant OperationsSkyepharma 2005 - Oct 2008Saint-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. -
Director ValidationCardinal Health 2003 - 2005Dublin, 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 ServicesMatirx Contract Services Jan 1996 - Feb 2003Associate 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.
Peter V. Skills
Peter V. Education Details
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San Diego State UniversityBiology
Frequently Asked Questions about Peter V.
What company does Peter V. work for?
Peter V. works for Trilink Biotechnologies, Part Of Maravai Lifesciences
What is Peter V.'s role at the current company?
Peter V.'s current role is Director Of Validation at TriLink BioTechnologies.
What is Peter V.'s email address?
Peter V.'s email address is pe****@****abs.com
What is Peter V.'s direct phone number?
Peter V.'s direct phone number is +171443*****
What schools did Peter V. attend?
Peter V. attended San Diego State University.
What skills is Peter V. known for?
Peter V. has skills like Gmp, Validation, Fda, Capa, V&v, Technology Transfer, Sop, Aseptic Processing, Biopharmaceuticals, Quality System, Pharmaceutical Industry, 21 Cfr Part 11.
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