Senior Process Engineer

As a senior member of the Process Engineering team, the successful candidate will be required to support complex and challenging process control initiatives that require understanding of analytical problem-solving techniques, project management, data analytics and Operational Excellence. This position is responsible for providing project leadership and daily operational support to the Upstream Process Engineering team at the Amgen Rhode Island site. Specific duties include:

• Lead and support of capital projects. This role involves the application of advanced engineering principles in the design, specification, construction, startup, and validation of process and GMP utilities equipment and systems for capital projects of significant scope and complexity.
• Lead and support technical root cause analysis, incident investigations, and troubleshooting on process control issues related to equipment (Stainless steel/Single Use), process, and control systems.
• Lead and support new product introductions or new technology introductions by performing engineering assessments, authoring engineering specifications, commission and qualification, and supporting engineering runs.
• Develop and implement innovative digital technologies in support of process, ergonomic, and business improvements
• Applying engineering principles to recommendation, design, and implementation of new equipment or system modifications
• Working closely with multiple disciplines, including manufacturing, automation, utility operations, maintenance, quality assurance, and validation to implement operational improvements
• Providing mentorship to Engineering team in daily operations and project execution
• Ensuring optimal and cost-effective performance and reliability for process systems
• Developing, organizing, analyzing, and presenting results for operational issues and engineering projects of moderate scope and complexity
• Provide technical support and issue resolution with 24x7 on-call support of process systems on a rotational based frequency.
• Communicating proactively with supervisor and support staff, highlighting issues and proposing solutions
  

Basic Qualifications

Doctorate degree

OR

Masters degree and 2+ years of directly related experience

OR

Bachelors degree and 4+ years of directly related experience

OR

Associates degree and 10+ years of directly related experience

OR

High school diploma / GED and 12+ years of directly related experience

Preferred Qualifications

• Bachelors Degree or Masters Degree in Chemical Engineering or related technical field
• 7+ years experience in engineering in a manufacturing support environment with at least 3 years experience in the Pharmaceutical or Biotechnology industries.
• Experience with Mammalian Cell Culture, Protein Purification, Clean Utilities, CIP, SIP and Production Services. Purification unit operation experience such as Chromatography and Ultrafiltration desired.
• Experience with Tech Transfer, Process Design, and Commissioning/Qualification
• Experience with validation and change control methodology
• Direct experience with regulated environments (i.e. cGMP, OSHA, EPA) including detailed understanding of cGMPs.
• Position requires excellent written and verbal communication skills and the ability to work with minimum direction.
• Demonstrated interpersonal and facilitation skills and ability to work in a collaborative team-based environment.
• Ability to apply analytical skills to evaluate and interpret complex problems using multiple sources of information
• Demonstrated ability to lead and influence cross-functional teams and embrace a team-based culture
• Familiarity with designing and operating equipment used in biopharmaceutical manufacturing

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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, or disability status.

Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.