|Date Posted||May 13, 2021|
LIFE SCIENCE COMMISSIONING ENGINEER TEAM LEAD
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.
We are looking for a Life Science Commissioning Engineer Lead. Commissioning Engineers perform commissioning testing on facilities and manufacturing equipment, author commissioning plans, risk assessments, commissioning protocol, and standard operating procedures. They provide client support for projects either independently or as part of a larger team.
In addition, Commissioning Engineers 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.
- Lead and mentor a team of less experienced commissioning engineers to complete the commissioning and operational readiness of one or more projects
- 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
- Provide document control strategies in support of projects
- Provide project planning, management, and execution as needed
- Execute project management activities to ensure projects are on time, within scope, and within budget
- Manage multiple projects and resources simultaneously
- Provide design qualification services by reviewing engineering drawings for accuracy and act to correct any errors
- 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
- Investigate any deviations; manage client Corrective and Preventative Actions (CAPAs) and provide data analysis and summary reports
- Develop and review spare parts lists; ensures spare parts are adequate and cost effective; and setup spare part rooms operations for clients
- Create preventive maintenance strategies and maintenance job plans
- 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
- Becomes a "Subject Matter Expert" (SME) in his/her area of expertise, and share knowledge through presentations, training sessions, or meetings
- Develop and manage quality control, document control, and communication plans
- Provide constructability and document reviews during project execution
- Manage project change control to ensure project remains compliant
- 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
- Maintain a positive attitude in a fast-paced environment
- Professional Engineering (PE) license required
- Engineering, Technical or Life Science degrees preferred
- 5-10 years of experience in project and commissioning
- Experience with 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)
- Proficient with 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) and guidelines
- Familiar 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 regulations
- Previous 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/or 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 requirements
- Organizational skills, oral & written communication, and team attitude
- Strong interpersonal skills and extremely resourceful in managing stakeholders
- Experience working in a corporate setting as a member of a project team or working independently with minimal supervision, if needed
- Strong understanding of mechanical, electrical, and automation systems: ability to read, interpret, and correct P&IDs, and experience with working in construction environments
- Detail-oriented with the ability to compile, analyze, summarize, and present data in a concise manner
- Excellent analytical skills and proven ability to solve problems creatively
- Strong familiarity with project management software tools, methodologies, and best practices
- Experience with seeing projects from conceptual design through operations
- Proven ability to complete projects according to outlined scope, budget, and timeline
- Proficient 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.