1 Amgen Center Dr. Thousand Oaks, CA 91320 US
Pay range is $33 - $36 per hour with full benefits available, including paid time off, medical/dental/vision/life insurance, 401K, parental leave, and more. Our compensation reflects the cost of labor across several US geographic markets. Pay is based on several factors including market location and may vary depending on job-related knowledge, skills, and experience.
THE PROMISES WE MAKE:
At Crystal Equation, we empower people and advance technology initiatives by building trust. Your recruiter will prep you for the interview, obtain feedback, guide you through any necessary paperwork and provide everything you need for a successful start. We will serve to empower you along the way and provide the path for your professional journey.
Top 3 Must Have Skill Sets:
- Engineering and technical background (process equipment, troubleshooting, data driven tech skills)
- Team work experience
- Project improvement background
- No work experience
- No engineering or technical experience
- No collaboration experience
Day to Day:
This engineering position supports manufacturing activities associated with manufacturing equipment and facilities at Thousand Oaks (TO). The engineer works in partnership with the maintenance, Project Management, Engineering Technical Lead, and manufacturing to develop and oversee the operation and reliability of equipment.
- Be individually accountable for the verification deliverables
- Assist in the identification of critical quality parameters and process attributes for new equipment or facility modifications.
- Assist in development and review of User Requirements Specifications (URS).
- Suggest design modifications to address risks and design in quality and safety.
- Oversee development of validation protocols in line with CQP, Automation Systems Delivery SOPs, and standards.
- Act as a liaison between Engineering and Manufacturing 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
- Review and approve the commissioning report and ensure that all verification exceptions have been adequately addressed
- Support Manufacturing and QA with Performance Qualification (PQ) activities if applicable.
- 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 on the CQP process and risk-based approaches to commissioning and verification
- Assist in developing and maintaining metrics
- Provide concise and clear documentation for actions taken on systems
- Master’s degree OR Bachelor’s degree & 2 years of engineering and/or manufacturing experience OR Associate’s degree & 6 years of engineering and/or manufacturing experience OR High school diploma / GED & 8 years of engineering and/or manufacturing experience
Preferred Qualifications / Skills / Experience:
- Bachelor's degree in engineering-related field
- 5+ years of relevant work experience with 3+ 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 process equipment / automation projects, including validation protocol development and execution
- Process equipment knowledge – cell culture, fermentation, purification, filling, and packaging
- Process automation knowledge – understanding of automation infrastructure, current technologies, and automation project execution / verification.
- Knowledge of Delta V, Rockwell, and Plant Information Systems is a plus
- Demonstrated 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
- 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 and applied engineering.
- Basic technical report writing and presentations
- Verbal communication
- Personal Organization
- Dealing with and managing change
- Technical (Equipment Specific)
- Analytical Problem Solving
- Computer Literacy (Maximo, Track wise, E-Builder, PCS, BMS and QEMS)
- Specialized equipment/process expertise
- Ability to handle multiple projects at the same time
- Schedule development, Facilitation and collaboration
- Basic project management, project completion and follow-up
- Problem solving skills requiring the application of scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach.
- Negotiation, persuasion and facilitation Collaboration
- Project Cost development
- Conflict Resolution
- Customer service in a technical setting
- Management of contractors and vendors.
- Flexibility to work off-hours and fully on-site