Manufacturing Engineer
4 weeks ago
Title: Senior Engineer
Location: West Greenwich, RI
Duration: 12 months
Top Skills:
Must have engineering degree (mechanical/ chemical engineering)
Must have experience with process equipment in pharma background, will be owning processing manufacturing equip (4-6 years of experience, not less than 4)
Must have experience with troubleshooting equipment / reliability background / problem solving
Not bio pharma need pharma manufacturing background
Preference is local but open to seeing job seekers with solid experience to relocating **If they are relocating they will be expected to be onsite within 2 weeks of offer
No gaps of more than 3-4 months in prior work experience
Will not accept PhD w/o industry experience
This engineering position supports manufacturing activities associated with manufacturing process equipment at Client Rhode Island (ARI).
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
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