Upstream Process Engineer
Amgen offers the opportunity to be at the interface between research, global development and manufacturing to ensure that these molecules become medicines. Many of the technologies we’re employing are not only new to Amgen but are new to the industry as a whole.
As a member of the Upstream Process Engineering team supporting ARI operations, responsibilities include:
Supports upstream manufacturing processes in two West Greenwich, Rhode Island clinical/commercial manufacturing plants. Responsibilities include providing operational support, troubleshooting, and optimization for assigned equipment; advising and applying engineering principles to the design and implementation of new equipment (Stainless and Single Use Systems)
Support system reliability and operational optimization efforts. Identify system performance risks (e.g. single point of failure or obsolescence) and implement risk reduction strategies. Lead and execute improvement efforts (including identifying cycle reduction time opportunities, efficiency gains, and yield improvement opportunities)
Lead or support technical root cause analysis, incident investigations, and solving on equipment (mechanical, electrical, instrumentation and control system problems). Previous training and experience is preferred.
Analyze problems, develop and propose engineering solutions in a scientific manner using data techniques and analyses (e.g. Statistical Process Control, Six Sigma, predictive maintenance analysis, etc.)
Support new product introductions or new technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs
Responsibilities will include support of capital projects. This role involves the application of process engineering principles in the design, specification, construction, startup, and validation of process equipment and systems for capital projects of moderate scope and complexity. Candidate should have previous exposure to project engineering processes from initial conceptualization through project turnover to operations.
Ensures the logical, detailed translation of design requirements and constraints into process equipment/system solutions. Assists with project definition by performing engineering studies and assessments for process equipment systems, clean utilities, and production facility improvements
Desired skills include demonstrated ability to translate production processes and user requirements into detailed designs aligned with industry practices; ability to apply standard engineering principles and practices to work assignments; and ability to employ basics techniques within area of engineering expertise
Support a safe working environment by aligning with all pertinent environmental health/safety practice, rules and regulations.
Bachelor’s degree and 2 years of Engineering experience
Associate’s degree and 6 years of Engineering experience
High school diploma / GED and 8 years of Engineering experience
Bachelor’s degree in Chemical Engineering, Mechanical Engineering, or Bioengineering preferred
3+ years of meaningful work experience with 1+ year experience in operations/manufacturing environment
Direct experience with regulated environments (e.g. FDA, cGMP, OSHA, EPA, etc.) is essential.
Hands-on experience with manufacturing process equipment including sophisticated troubleshooting, reliability and performance improvements, and design optimization.
Direct experience in equipment engineering and solving issues with fermenters, bioreactors, centrifuges, chromatography columns and systems, and/or ultrafiltration/defiltration systems.
Solid understanding and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, facilities, and equipment. Candidate should be experienced in change control, Deviations, corrective and preventative actions, and validation practices
Experience supporting design and startup engineering directly related to bulk biopharmaceutical production including process equipment and facilities design, procurement, construction, startup, and validation is preferred.
Must be independent, self-motivated, organized, able to multi-task in project environments, and skilled in communication, facilitation, and collaboration.
Individual must be a teammate prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.
Ability to apply sophisticated and diverse engineering principles to the design and implementation of major system modifications, introduction of new processes, and capital projects. Develop technical solutions to sophisticated problems requiring the regular use of resourcefulness and creativity.
Strong leadership, technical writing, and communication/presentation skills are required.
Work schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverage.
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like sophisticated human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.
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.
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