Commissioning Engineer (All Levels) - Life Sciences (option for 1099)

35 North-posted 11 days ago

Full-time • Entry Level

Durham, NC

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35 North is a full-service program and project management firm that provides consulting, construction, cost and commissioning solutions for life sciences capital projects. We are a growing company with many opportunities to make an impact, especially in the high-growth sectors of biotechnology and life sciences. Expand your career and discover opportunities with 35 North. The Commissioning Engineer will support commissioning testing on facilities and manufacturing equipment; author commissioning plans, risk assessments, commissioning protocol, and standard operating procedures; and provide client support and project management for projects as part of a larger team. Successful candidate may be hired level I, II, III -Senior based on education + years of relevant experience.

Generate documents such as commissioning master plans, design qualification, equipment, facility and utility commissioning protocols, and final reports
Perform commissioning and qualification testing on utilities and manufacturing process equipment and instruments
Review and assess systems
Develop and review design specifications and engineering drawings to determine if systems meet project intent
Review equipment specifications, user manuals, and engineering documentation to understand systems operation; test equipment and systems to assure they meet project requirements
Develop and review spare parts lists; ensures spare parts are adequate and cost effective; and setup spare part rooms operations for clients
Perform system walk-downs and testing, identify gaps and non-conformances; analyze options and solutions; and make technical changes to systems
Participate in professional organizations such as ISPE, PDA, ASQ, NCEES, NCBELS, AERGC or other professional organizations relevant to their area of expertise
Provide project commissioning updates on a consistent basis to various stakeholders
Work collaboratively and build effective relationships with Client's project team, owners and final users, design team, contractors, and local jurisdictional personnel
Maintains a positive attitude

BS in engineering or life sciences OR an equivalent combination of experience & education

3+ years of experience in the commissioning field
Experience with clean utilities
Experience interacting with clients to identify project needs
Organizational skills, oral & written communication
Strong interpersonal skills and experience managing stakeholders
Experience working in a corporate setting as a member of a project team
Capable technical writer of documents such as: commissioning master plans (CMP): user requirements specifications (URS): risk assessments (RA): design qualification (DQ): factory acceptance tests (FAT): site acceptance tests (SAT): pre-functional tests (PFT): functional tests (FT): commissioning test plans (CTP): integrated system tests (IST): maintenance, calibration and spare parts assessments and plans: standard operating procedures (SOP)
Knowledge of mechanical, electrical, and automation systems
Ability to read and interpret P&IDs
Experience working in construction environments
Detail-oriented with the ability to compile, analyze, summarize, and present data in a concise manner, analytical skills, and ability to solve problems creatively
Familiarity with commissioning software tools, methodologies, and best practices
Experience working in regulated industries and knowledge of regulatory and compliance requirements

401k with 3% employer contribution
Cell Phone Allowance
Employer paid life insurance and long-term disability
Full medical, dental, and vision benefits
Paid time-off and holidays

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Commissioning Engineer (All Levels) - Life Sciences (option for 1099)

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