Must be available for potential on call for Overtime looking at potentially 10-12 hours a month.
This engineering position supports manufacturing activities associated with cGMP equipment and facilities at Amgen Thousand Oaks (ATO). The engineer will lead activities in alignment with Amgen's Commissioning and Qualification Process (CQP) to ensure that new GMP equipment is installed and maintained in a validated state. This role will collaborate with the maintenance, project management, the engineering technical lead, and manufacturing to develop and oversee the implementation, operation and reliability of equipment. The engineer will work closely with Quality Assurance (QA) to ensure GMP compliance and address potential gaps. In addition, the engineer will evaluate equipment maintenance plans, support periodic review of manufacturing systems, and investigate root causes of equipment issues. The engineer 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 / Experience • Bachelor's degree in engineering or another science-related field • 2+ years of relevant work 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 • Demonstrated strong communication and technical writing skills • Strengths in facilitation and collaboration / networking with cross-functional groups • Experience in developing SOPs and delivering training • Individual must be a team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making • Proven track record of applying process improvement methodologies to mature and improve business processes (e.g. PDCA, LEAN, Six Sigma, and fundamental understanding of statistics, etc.) • Problem solving skills using scientific and engineering methods and investigative skills for root cause analysis. • Availability to support outside regular hours as needed • Demonstrate skills in the following areas:
? Problem solving and applied engineering.
? Basic technical presentations.
? Personal organization.
? Adapting to and managing change.
? Project and document management systems (CDOCS, E-Builder, PCS, BMS and QEMS).
? Validated GMP management systems (Maximo CMMS, Trackwise)
? Project management and cost development
? Conflict Resolution
? Leadership and team building
Basic Qualifications
Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience
Top 3 Must Have Skill Sets: • Demonstrated strong communication and technical writing skills with cross functional groups, (QA, MFG., Leadership) • Direct experience with regulated environments (FDA, OSHA) with an emphasis in promoting safety and quality in their area of work. • Bachelor's degree in engineering or another science-related field with 2+ years of relevant work experience in operations/manufacturing environment