|Date Posted||June 10, 2021|
LIFE SCIENCE COMMISSIONING ENGINEER Are you looking for a career with a sense of purpose? Our purpose is to help our clients achieve theirs! Join a company that provides decisive and measurable solutions for complex challenges in the Life Science Industry. We turn what can be challenging situations into actionable and realistic solutions. Among our many exciting projects, we have helped clients"Feed the World,""Detect Cancer Early, when it Can be Cured,""Create the First Bioengineered Human Acellular Vessel (HAV),""…unites caring with discovery to create medicines that make life better for people around the world","…target unmet medical need in ocular and rare diseases…" and,"Lower the Cost of Life-Saving Pharmaceutical and Biotechnology Products to Improve the Life of All Patients" 35 North is a full-service program, project, and construction management firm that delivers customized innovative solutions focused on the Life Science industry. We work on a variety of project sizes and types. Our expert, in-house team provides program and project management, construction management, cost estimating and management, scheduling, and commissioning services. We are searching for self-motivated and energetic individuals interested in being part of a small but growing company. We are looking for people that feel energized by the satisfaction of solving complex problems and helping our clients fulfill their purposes to make the world a better place for all. We are seeking the next generation leaders to contribute shaping 35 North into a top consulting employer. This is a full-time, permanent position in a fast-paced environment. The role could alternate between our HQ office located in the Research Triangle Park, NC, and Clients' locations. Job Overview: Commissioning Engineers perform commissioning testing on facilities and manufacturing equipment; author commissioning plans, risk assessments, commissioning protocol, and standard operating procedures; and, provide client support for projects either independently or as part of a larger team. Additionally, Commissioning Engineers initiate, develop, and lead projects and teams at client sites. They are accountable for project initiation, inception, design, development, implementation, management, follow-up, and maintenance. Commissioning engineers take an active approach to champion projects and providing client support. Commissioning Engineers also provide Operational Readiness services. This includes developing all necessary maintenance standard operating procedures and identifying preventative maintenance activities and critical calibration requirements for each piece of equipment. They also develop comprehensive preventative maintenance and calibration programs to be uploaded into our clients' CMMS or CCMS systems. Primary Responsibilities: Generate documents such as commissioning master plans, design qualification, equipment, facility and utility commissioning protocols, and final reportsPerform commissioning and qualification testing on utilities and manufacturing process equipment and instrumentsProvide document control strategies in support of projectsProvide design qualification services by reviewing engineering drawings for accuracy and act to correct any errorsReview and assess systems; develop and review design specifications and engineering drawings to determine if systems meet project intentReview equipment specifications, user manuals, and engineering documentation to understand systems operation; test equipment and systems to assure they meet project requirementsInvestigate any deviations; manage client Corrective and Preventative Actions (CAPAs) and provide data analysis and summary reportsDevelop and review spare parts lists; ensures spare parts are adequate and cost effective; and setup spare part rooms operations for clientsCreate preventive maintenance strategies and maintenance job plansPerform system walk-downs and testing, identify gaps and non-conformances; analyze options and solutions; and make technical changes to systemsParticipate in professional organizations such as ISPE, PDA, ASQ, NCEES, NCBELS, AERGC or other professional organizations relevant to their area of expertiseProvide project commissioning updates on a consistent basis to various stakeholdersWork collaboratively and build effective relationships with Client's project team, owners and final users, design team, contractors, and local jurisdictional personnelMaintain a positive attitude in a fast-paced environmentRequired Qualifications: Engineering, Technical or Life Science degrees preferredLess than 5 years of experience as commissioning engineer for junior levels, 5-15 years of experience as commissioning engineer for proficient levels, 15+ years of experience as commissioning engineer for senior levelsProficient at technical writing 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): procedures: and, guidelinesExperience working on regulated industries and knowledge of regulatory and compliance requirements: FDA regulations, USDA regulations, Good Engineering Practices (GEP), current Good Manufacturing Practices (cGMP), and Good Documentation Practices (GDP)Familiarity with the Code of Federal Regulations (CFR) as related to cGMP in Manufacturing, Processing, Packaging, and Holding of Drugs and Finished Pharmaceuticals; Dietary Supplement & Human Food; Biological Products & General Biological Products Standards; Good Clinical Practices for Medical Devices; and, Quality Systems regulationsPrevious project experience in one or more of the following technologies and platforms: manufacturing and utilities systems; clean and aseptic rooms; clean-in-place (CIP); steam-in-place (SIP); autoclaves; vapor hydrogen peroxide (VHP) sterilization; solid dose preparation areas; powder feeding and continuous manufacturing; blending, milling, granulation, and formulation; fermentation, purification, and conjugation processes,; controlled temperature environments; injectables sterile fill and packaging facilities; conveyors and clean packaging automation; GMP warehousing; and, automated storage and retrieval warehouse systems.Successful experience interacting with clients to identify project needs and work towards solutions that meet schedule, cost, and quality expectations and requirementsOrganizational skills, oral & written communication, and team attitudeStrong interpersonal skillsStrong understanding of mechanical, electrical, and automation systems: ability to read, interpret, and correct P&IDs, and experience with working in construction environmentsDetail-oriented with the ability to compile, analyze, summarize, and present data in a concise mannerExcellent analytical skills and proven ability to solve problems creativelyProficient with computerized systems, information technology, and information systems related to project and construction software packages Compensation will be determined based on education, years of commissioning experience, and alignment within the Life Science industry.