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.
Engineering Manager-Upstream ManufacturingLive
What you will do
Lets do this. Lets change the world. In this role the engineering manager is responsible for leading a group within the B7 team and responsible for manufacturing equipment and reliability. This role will bring to bear continuous improvement, transformative approaches and innovation to drive reliability, efficiency, agility and differentiation. This engineering manager position supports commercial manufacturing activities associated with cGMP equipment and facilities at Amgen Thousand Oaks (ATO). The position will provide alignment with Amgens engineering practices and standards to ensure that equipment is installed and maintained in a validated state. The engineering manager works in partnership with quality assurance, automation, maintenance, project management, and manufacturing. The manager will support capital and department projects in defining strategies and successful project execution.
The manager will be strong leader that has direct engineering technical support oversight and responsibilities include:
- Drive a culture of continuous improvement
- Deliver strong business results
- Building a Strong Organizational Alignment
- Ensure the right people and resources are in place and optimally allocated to achieve results
- Create an environment that fosters accountability, innovation, continuous improvement, learning and knowledge-sharing
- Ensure effective decision-making and clear and timely communication
- Attracting, Developing and Retaining Diverse Talent
- Builds and develops a diverse, impactful team
- Conducts short and long-range talent planning to ensure readiness of talent to implement future organizational objectives
- Works across functions to build organization and individual capabilities
- Develops strong relationships with staff members, provides open and clear feedback to improve individual and team performance
- Drive the safety and quality of the engineering organization.
- Be accountable for the verification work on key capital projects
- 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.
- Develop and critique engineering strategy based on the URS and Quality Risk Assessment for Automation and Equipment Systems (QRAES) while minimizing project cost and schedule impact (risk-based approach).
- Oversee development of validation protocols in line with CQP, Automation Systems Delivery SOPs, and cGMP standards.
- Recommend, evaluate, and manage performance of contract resources
- Provide oversight for verification work developed by outsourced/contract verification staff.
- Act as a liaison between Engineering and Quality Assurance during project planning, implementation, and closeout
- Ensure that validation protocols are completed 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.
- Manage a team engineers to address department goals and corporate objectives.
- 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
- Defend the equipment-specific calibration, maintenance, & validation as required during regulatory inspections
- Participate in internal audits and assess in conjunction with QA.
- Assist in developing and maintaining metrics
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The engineering professional we seek will possess these qualifications.Basic Qualifications:
Master's Degree and 3 years of engineering and/or manufacturing experience
Bachelor's Degree and 5 years of engineering and/or manufacturing experience
Associate's degree and 10 years of engineering and/or manufacturing experience
High school diploma/GED and 12 years of engineering and/or manufacturing experience
Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resourcesPreferred Qualifications:
- Strong leadership and teambuilding skills (coaching, mentoring, counseling)
- Experience with Lean Principles and continuous improvement
- Experience with performance management including conflict resolution and performance evaluations
- Analytical problem-solving skills
- Project Management skills
- Thorough understanding of regulatory requirements
- Ability to be flexible and manage change
- Excellent verbal and written communication (technical) skills.
- 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.)
- 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
- Strong process equipment knowledge cell culture, fermentation, purification, and filling
- Strong process automation knowledge understanding of automation infrastructure, current technologies, and automation project execution / verification.
- Working based knowledge of Delta V, Rockwell, and Plant Information platforms
- 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
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 $109,157 to $134,037.
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.