Process Development Engineer

Description:

This engineering position supports manufacturing activities associated with cGMP equipment and facilities at Amgen Thousand Oaks (ATO). The engineer works in partnership with the automation, maintenance, project management, corporate engineering, and manufacturing to develop and oversee the operation and reliability of equipment while driving safety and quality compliance. The engineer will support the department and capital projects and provide data to support business cases and long term strategy.

The Engineer role will provide direct engineering technical support as follows:

• Model leadership behaviors and positive values to create a positive working environment.

• Be individually accountable for the consistent equipment performance

• Be accountable for assigned deliverables on key capital projects

• Suggest design modifications to address risks and design in quality and safety.

• Provide oversight for verification deliverables developed by outsourced/contract verification staff.

• Act as a liaison between Engineering and Quality Assurance during project planning, execution, and closeout

• Ensure that validation protocols are executed and documented in accordance with cGMP good documentation and safety compliant practices.

• Ensure safety during commissioning, validation, maintenance, and manufacturing activities

Related Activities:

• Participate or lead, when required, multidisciplinary site teams, e.g. Cross Functional Team, Root Cause Analysis lead.

• Support Lean Transformation and Excellence in Operations process improvement by leading, supporting, and documenting improvement opportunities to reduce cost, improve safety/quality, or improve speed.

• Provide ad hoc technical support and guidance for manufacturing and maintenance

• Provide coaching and guidance to project teams and engineers using risk-based approaches

• Defend the equipment-specific calibration, maintenance, & validation as required during regulatory inspections

• Participate in internal audits and assess in conjunction with quality assurance

• Assist in developing and maintaining business metric performance

Preferred Qualifications / Skills / Experience

• Bachelor's degree in engineering or another science-related field

• 7+ years of relevant work experience with 5+ 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 – basic principles of cell culture, fermentation, purification, filling

• Process automation knowledge – fundamental understanding of automation infrastructure

o Knowledge of Delta V, Rockwell, and Plant Information Systems is a plus

• Strong communication and technical writing skills

• Strengths in facilitation and collaboration / networking

• 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

• Basic understanding of process improvement methodologies to mature and improve business performance (examples: PDCA, LEAN, Six Sigma, etc.)