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Senior Process Engineer

3 months ago

West Greenwich, United States ACL Digital Full time

Job Title: Engineer Senior

Location: West Greenwich, RI

Duration: 12+ Months

** Need process equipment troubleshooting experience in their resumes.

Examples of process equipment that we are looking for are: Bioreactors, Chrom skids, TFF skid, CIP skids, Filtration skids --- ideal candidate has manufacturing engineer experience in a pharmaceutical industry

Must Haves:

4 to 6 years Engineering and technical background on process equipment in pharmaceutical industry

Has shown cross functional collaboration with multidiscipline functions such as process development, engineering, automation, maintenance and management

This engineering position supports manufacturing activities associated with manufacturing process equipment at Amgen Rhode Island (ARI).

The engineer works in partnership with the maintenance, Project Management, Engineering Technical Lead, and manufacturing to develop, improve and oversee the operation and reliability of equipment.

Preferred Qualifications / Skills / Experience

• Bachelor’s degree in chemical or other Engineering fields

• 6+ years of relevant work experience with 5+ years experience in Biopharmaceutical operations/manufacturing environment

• Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.) and familiarity with GMP quality systems/processes such as change control, nonconformances

corrective and preventative actions, and qualifications/validation.

• Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility equipment/systems such as cell culture reactors, chromatography, filtration, as well as other equipment needed to support these processes such as autoclaves, clean in place (CIP) systems, washers, clean steam, etc.

• Ability to analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g., Root Cause Analysis (RCA), Statistical Process Control (SPC), Six Sigma, Predictive Maintenance, etc.)

• Experience applying engineering principles to the design and implementation of system modifications, introduction of new processes, and execution of capital projects

• Understanding of the execution process of capital projects in a GMP and/or non-GMP

Biopharmaceutical Production facility including procurement, construction, startup, and validation

• Understanding of safety requirements working in a Biopharmaceutical Production facility.

• Independent, self-motivated, organized, able to multi-task in project environments, and skilled in communication, facilitation, and collaboration

• Phenomenal teammate prepared to work in and adopt a team based culture that relies on collaboration for effective decision-making

• Strong leadership, technical writing, and communication/presentation skills