Description:Looking for a Senior level PM who will support manufacturing plant and engineering group, This person needs to have process/utility Engineering technical experience and not only be quality background driven.
Responsibilities:This engineering position supports projects that associated with cGMP equipment and facilities at Thousand Oaks (ATO). The engineer will lead project engineering and construction activities in alignment with the engineering workstreams (i.e. Trades during construction, project management budget, schedules, safety, and Commissioning and Qualification Process (CQP) to ensure that new GMP equipment is installed and maintained in a validated state, equipment & facilities design and compliance, project management, etc.).
The staff works in partnership with the maintenance, Project Management, Engineering Technical Lead, and manufacturing to develop and oversee the operation and reliability of equipment.
The position must work closely with Environmental Health Safety Services (EHSS) and Quality Assurance (QA) for compliance.
The position will support the projects in defining strategies for quality systems verification and will work with the process development / validation team to develop and document appropriate practices for characterization.
Preferred Qualifications / Skills / ExperienceBachelor's degree in engineering or another science-related field
2+ years of relevant work experience with 1+ years' experience in operations/manufacturing environment
Direct experience with regulated environments (FDA, OSHA, EPA, etc.)
Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, clean utilities, facilities, instruments and equipment
Experience implementing risk-based verification on major GMP process equipment / automation projects, including validation protocol development and execution
Experience with combination product / medical device quality systems verification
Process equipment knowledge - cell culture, fermentation, purification, filling, and packaging.