Commissioning Manager

Sequoia Consulting Group provides world-class consulting services to the life sciences industry. Our team manages projects in automation, facility design, engineering, manufacturing, quality, regulatory affairs and validation at a variety of clients within the biotechnology industry. Sequoia's hands-on consultants provide technical knowledge and relevant life science experience to establish best practices in manufacturing, pharmaceutical and medical device companies. We are helping to produce better, faster and more economically priced medicines and medical devices around the world.

Responsibilities/ Qualifications:

• Experience acting as owner's representative on a large complex construction project (this is with a preference for lab / office or cGMP manufacturing projects).
• Experience working on multi-employer sites (more than one contractor on a single construction site).
• Familiarity with taking a project from design through construction and into commissioning.
• Written the commissioning strategy/plan and protocols for a least one large project.
• Familiarity with reviewing technical submissions from all team members: Architectural and Engineering firms, System Integrators, equipment manufacturers, the owners own engineering groups (local and global) with an eye to ensuring you have everything necessary to install and commission all systems in the building.
• Familiarity with answering common construction communications like RFIs, Submittals, etc.
• Experience working as part of a larger construction team to schedule the work of the commissioning team and the moving company to meet both cost and schedule targets. You will have experience supervising a large sub-contractor team that will start-up and commission all equipment in a large capital project.
• Experience coordinating the purchase, receipt, and movement of equipment into a facility that may not be complete from construction perspective.
• Experience scheduling the decommissioning, packing, movement, and ultimate unpacking of large amounts of equipment from one facility to another.
• Familiarity with reviewing all construction site safety documents like work permits, task plans, job hazard analyses and ensuring the System Integrator executes all work in compliance with the procedures and with safety as the highest priority.
• Familiarity with walking construction sites, taking part in all daily planning meetings, making and documenting observations
• Familiarity with at least one project / construction management software package like: ProCore, E-Builder, Prolog, etc.
• Familiarity with the design, start-up, commissioning, and hand over of common lab and office building systems like Building Automation Systems (BAS), HVAC systems, emergency power and UPS systems, lab gases, RODI water, boilers, steam generators, etc (a plus would be to have experience doing this in a GMP environment but is not required).
• Familiarity with writing all the necessary operational and maintenance SOPs for all building systems the like: calibration procedures, preventative maintenance, lock out tagout, access control, etc.
• Had success in closing out a large project and ensuring that all necessary documentation is in place, is accurate and all financial obligations are met.
• Familiarity with a CMMS like Maximo, Blue Mountain, etc. and getting large numbers of assets set up inside the CMMS.

Though not a requirement, a few pluses will be if you have experience:

• Starting up and commissioning common lab equipment like Mass Spectrometers, HPLCs, NMRs, sample handling robots, etc. (barring direct commissioning experience – a plus would be coordinating and scheduling vendor SMEs to get this equipment commissioned as required by schedule on a large capital project)
• Commissioning advanced energy control systems like: power monitoring and lighting control.

In addition, you will have:

• An engineering degree (mechanical, electrical, construction)
• 15 -20 yrs. experience on large, complex engineering projects preferably in a mix of validation contractors and operating companies as a project engineer / manager.
• 5-7 years of relevant experience within the biotech industry with proven knowledge of current Good Manufacturing Procedures (cGMP) compliance
• An OSHA – construction certification
• A deep understanding of safe construction practices and standards
• Strong leadership, collaboration, communication, prioritization, and problem-solving skills
• Highly motivated, independent, detail-oriented team player with good organization, initiative, and a collaborative attitude is essential

Sequoia offers a comprehensive suite of benefits including medical, dental, vision coverage, 401k, and company paid life-insurance. Sequoia is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. Unfortunately, Sequoia is unable to provide any visa sponsorship at this time. All your information will be kept confidential according to EEO guidelines.