Engineer

Let’s do this. Let’s change the world. In this vital role you will working in partnership with Facilities & Engineering, 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). 

• 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 case 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 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.
• Partnering 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 deliverables developed by outsourced/contract verification staff.
• Act as a liaison between cross-functional teams 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
• Support Manufacturing and QA with Performance Qualification (PQ) activities if applicable.

We are all different, yet we all use our unique contributions to serve patients. The Engineer professional we seek is an individual with these qualifications.

Basic Qualifications:

Doctorate degree
OR
Master’s degree and 2 years of engineering and/or manufacturing

experience
OR
Bachelor’s degree and 4 years of engineering and/or manufacturing experience
OR
Associate’s degree and 8 years of engineering and/or manufacturing experience
OR
High school diploma / GED and 10 years of engineering and/or manufacturing experience

Preferred Qualifications:

• Bachelor's degree in engineering or other science-related field
• 8 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 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.)
• 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
• Understanding and awareness of industry/regulatory trends for verification/validation
• Strong process equipment knowledge – cell culture, fermentation, purification, filling, and packaging; facilities, utilities and equipment
• 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 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.)

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of 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 that may include:

• A 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
• Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship for this role is not guaranteed.

Salary Range