1 Amgen Center Dr. Thousand Oaks, CA 91320 US
Pay range is $31 - $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:
- Fundamental Leadership and Values
- Good Communication / Safety / Quality Focused
- Fundamental Technical Knowledge
Person will be working in a manufacturing environment but in this posting we are looking for an engineer with strong ANALYTICAL skills and background
- Safety not recognized as top priority
- Poor communication
- Has issues under stressful situations
- Blames other for negative situations
This engineering position supports manufacturing activities associated with cGMP equipment and facilities at Thousand Oaks (TO). The engineer will lead activities in alignment with our 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.
- Be individually accountable for the verification deliverables on key capital projects.
- Assist in the identification of critical quality parameters and process attributes for new equipment or facility modifications.
- Oversee development of validation protocols in line with CQP and cGMP standards.
- Lead, evaluate, and manage performance of contract resources.
- Provide oversight for verification deliverables developed by outsourced/contract verification staff.
- Act as a liaison between Engineering, Manufacturing, 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.
- Review and approve the commissioning report and ensure that all validation exceptions have been adequately addressed.
- Conduct and document periodic equipment validation reviews.
- Perform equipment troubleshooting and root cause investigations using LEAN tools (Fishbone, 5-Why, etc.)
- 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
- Provide coaching and guidance to project teams and engineers on the CQP process and risk-based approaches to commissioning and verification
- Defend the equipment-specific calibration, maintenance, & validation as required during regulatory inspections
- Participate in internal audits and assess risks in conjunction with QA.
- Assist in developing and maintaining metrics related to equipment performance
- Provide technical expertise to develop reliability improvement plan including design requirements, maintenance strategy, spare part procurement.
- Lead improvement implementation plans while following safety requirements
- Assist with equipment maintenance and troubleshooting during project duration
- Introduce and implement new analytical systems to improve reliability when needed. Lead implementation plan to ensure new systems are implemented per our requirement.
- Contact vendors as needed to understand and assess any change impact (to equip, utility, facility) as improvements are planned and executed.
- Develop GMP documentation following good documentation practices including validation plans and standard operating procedures.
- Master degree
- Bachelor degree and 2 years of experience
- Associate degree and 6 years of experience
- High school diploma / GED and 8 years of experience
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