Career Category

Job Description

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

Master’s degree and 3+ years of directly related experience

OR

Bachelor’s degree and 5+ years of directly related experience

OR

Associate’s degree and 10+ years of directly related experience

OR

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

Preferred Qualifications

• Bachelor’s Degree or Master’s 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