HOW MIGHT YOU DEFY IMAGINATION?
Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.
Senior Project Management EngineerLive
What you will do
Lets do this. Lets change the world. In this role the Senior Project Management Engineer works in partnership with the maintenance, process development, project management, engineering technical authority, and manufacturing to develop project scope, schedule, budget and lead the implementation workstream. Responsibilities include working closely with Quality Assurance (QA) for GMP and Safety for safety compliance. The engineer will support the projects in defining strategies for systems verification and will work with the process development / validation team to develop and document appropriate practices. This position supports manufacturing activities associated with cGMP equipment and facilities at Amgen Thousand Oaks (ATO).
The Engineer/Project Manager role will provide direct engineering technical and project support as follows:
- Be individually accountable for the deliverables on projects.
- Identify, support, and/or lead implementation of engineering-based improvements or upgrades to the equipment or facility systems. This may include development of business argument for improvement and identification of design requirements and then translation of requirements into process equipment/system design, specification and supporting the construction, startup, and validation of equipment.
- Develop and present project charters/strategies to leadership.
- Developing accurate estimates & schedules, with cost and schedule risk analysis, cash flow analysis and data for benchmarking.
- Leads the team effectiveness by: Identifying and efficiently resolving issues, facilitating and documenting decisions, and tracking action items; following appropriate escalation process
- 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).
- Identify risks (business, quality, and safety) and develop mitigation countermeasures that are implemented.
- Partner with commissioning lead to develop the commissioning strategy based on the URS and Quality Risk Assessment for Automation and Equipment Systems (QRAES) to validate equipment design while minimizing project cost and schedule impact (risk-based approach).
- Recommend, evaluate, and manage performance of contract resources
- Provide oversight for verification work developed by outsourced/contract verification staff.
- Act as a liaison between cross-function teams during project planning, execution, and closeout
- Ensure that validation protocols are performed and detailed in accordance with cGMP good documentation and safety compliant practices.
- Ensure safety during commissioning, validation, maintenance and manufacturing activities
- Support Manufacturing and QA with Performance Qualification (PQ) activities if applicable.
- Participate or lead, when required, multidisciplinary site teams, e.g. Multi-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
- Coaching and guidance to project teams and engineers on the CQP process and risk-based approaches to commissioning and verification
- Participate in internal audits and assess in conjunction with QA.
- Assist in developing and maintaining project metrics
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Project Management professional we seek will possess these qualifications.Basic Qualifications:
Masters degree & 3 years of engineering and/or manufacturing experience
Bachelors degree & 5 years of engineering and/or manufacturing experience OR
Associates degree & 10 years of engineering and/or manufacturing experience
High school diploma / GED & 12 years of engineering and/or manufacturing experiencePreferred Qualifications:
- Bachelor's degree in engineering or other science-related field
- 7 or more years of relevant work experience in operations/manufacturing environment
- 5 or more years of engineering or construction experience in the pharmaceutical/biotechnology/regulated chemical manufacturing industry executing on projects (Project Managing, Planning, Estimating, Cost Management, Scheduling, Technical Engineering Support)
- Direct experience working within regulated environments (FDA, OSHA, EPA, etc.)
- 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
- Understanding and awareness of industry/regulatory trends for verification/validation
- Strong process equipment knowledge cell culture, fermentation, purification, filling, and packaging
- Strong 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 standout colleague prepared to work in and embrace a team-based environment that relies on collaboration for effective decision-making
- 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.
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.
The annual base salary range for this opportunity in the U.S. is $111,913 to $132,048.
In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:
- Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans and bi-annual company-wide shutdowns
- Flexible work models, including remote work arrangements, where possible
for a career that defies imagination
Objects in your future are closer than they appear. Join us.careers.amgen.com
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.