Sr Project Engineer

Career Category

Job Description

Join Amgens Mission of Serving Patients

At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980 weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology Inflammation General Medicine and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer heart disease inflammatory conditions rare diseases and obesity and obesity-related conditions. As a member of the Amgen team youll help make a lasting impact on the lives of patients as we research manufacture and deliver innovative medicines to help people live longer fuller happier lives.

Our award-winning culture is collaborative innovative and science based. If you have a passion for challenges and the opportunities that lay within them youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Engineer

What you will do

Lets do this. Lets change the 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.

What we expect of you

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
Masters degree and 2 years of engineering and/or manufacturing

experience
OR
Bachelors degree and 4 years of engineering and/or manufacturing experience
OR
Associates 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:

• Bachelors 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.)

What you can expect of us

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 well 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.

Apply now and make a lasting impact with the Amgen team.

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.

Application deadline

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

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world Amgen fosters an inclusive environment of diverse ethical committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race color religion sex sexual orientation gender identity national origin protected veteran status disability status or any other basis protected by applicable law.

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.

Salary Range