Cornerstone Commissioning LLC. – Boston, MA or Washington, D.C. area - Full Time

*This is a remote position but must be located in the Greater Boston area or the Northern VA/ Washington, D.C. area.

Who are we?
The TSS Family of Companies is a leading compliance, calibration, commissioning, and certification service provider for laboratories, hospitals, and pharmacies with locations across the United States.
Cornerstone Commissioning is an industry-leading commissioning firm offering independent laboratory facility performance services for design teams and building owners by verifying facilities meet owner’s project requirements. Cornerstone specializes in biocontainment facilities, including BSL-3 laboratories.

How will you make an impact?
Our Commissioning Engineers are a key player in our organization with the ability to work on exciting life science and other mission critical projects. We are looking for a high potential leader ready to take on the challenge of independently leading and managing Mechanical, Electrical, Plumbing (MEP) commissioning projects from award to turnover to the client. You will have responsibility for fostering a high-performance culture, the satisfaction of your customers, loyalty of your co-workers, and the leadership and development of a best-in-class team of commissioning agents.

What will you do?
Develop fundamental commissioning practices and technical competencies related to building Mechanical, Electrical, Plumbing and building automation control systems. This includes:
• Supporting client relationships for multiple commissioning projects.
• Supporting reviews of MEP design documents: drawings and specifications and equipment submittals to ensure owner’s project requirements are met.
• Reviewing MEP system controls sequences and participating in meetings to clarify and improve the sequences through final version.
• Proficiently generating all Cx documentation including commissioning plans, commissioning specifications and commissioning reports using company templates and standards in BlueRithm (Cornerstone’s commissioning software).
• Generating pre-functional checklists using company templates and standards, then performing and documenting pre-functional checks of installed equipment on site, coordinating, and building rapport with contractors in the process.
• Performing construction site visits to review installation progress and readiness of systems for testing and to identify and document discrepancies and issue resolution.
• Generating Commissioning Issues Reports (CIRs) to document issues and discrepancies discovered on site.
• Writing system-specific functional performance test scripts from equipment submittals and final control sequences, using company templates and standards.
• Possessing thorough knowledge and understanding of the Building Automation System (BAS) and being able to use and manipulate BAS independently from contractors/owner personnel to review trends, alarm history and perform zone (room) performance testing.
• Possessing thorough knowledge and understanding of the Building Automation System (BAS) and being able to use and manipulate BAS independently from contractors/owner personnel to review trends, alarm history and perform zone (room) performance testing.
• Leading, documenting, performing, and troubleshooting integrated system tests (aka, system failure scenarios).

How will you get rewarded?
TSS offers competitive salaries and a wide range of benefits:
• Salary range of $70,000- $85,000 annually
(Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with industry data.)
• Medical, vision and dental insurance
• 401(k) plan with a company matching contribution
• Long-term disability, short-term disability, and life insurance
• Competitive Paid Time Off (PTO) and company paid holidays

What do you bring?
Education and Experience
• Requires 0-3 years of experience in the commissioning or building controls industry.
• Demonstrate exceptional oral, written communication, and project management skills.
• Must have some technical competencies in Mechanical, Electrical, Plumbing, and building automation systems.
• A combination of education, experience and training may meet requirements.
Knowledge, Skills, and Abilities
Demonstrate exceptional communication skills in all situations:
• Be effective at motivating project teams to engage in the commissioning process.
• Strong oral and group dynamic skills are required. Must be able to professionally lead meetings and technical projects with a broad audience of varying skills and backgrounds.
• Be a proficient writer who can succinctly communicate and manage information throughout all phases of a project (including commissioning documentation, reports, emails, etc.).
• Maintain a high level of transparency and open communication in a virtual, remote work environment.
• Conduct all communication in a winsome way.
Possess and continually develop technical competencies related to MEP, BAS, and associated specialty systems:
• Be able to read and understand MEP and architectural construction documents.
• Perform and collaborate with hands-on troubleshooting of MEP and BAS controls systems. “Hands-on” means connecting our PCs to a building control system to monitor and evaluate system performance.

Cornerstone Commissioning is a passionate equal opportunity employer and celebrates diversity. Interested in a role but not sure it’s the right fit for you? Call us and let’s talk.

Seeking a Facilities Engineer with experience in the management, execution, and day to day support of building and plant operation including labs, manufacturing plants, utilities, equipment and systems. This individual will be working closely within the Facilities and Engineering group and will be providing support by assisting with the planning and execution of renovations within clean suites. This position will be conducted during weekly production turnover periods which necessitates the support of work on Monday-Friday and two Saturdays a month through out the project lifecycle.

Responsibilities 

Schedule, coordinate and oversee outside service providers for routine CM and PM Program tasks provided under building, system, or equipment maintenance contacts. 
Support with PIDs, HVAC, electrical, one-lines, and process flow diagrams (PFDs). 
Support team with active construction. 
Ensure all CM and PM Program tasks are completed and documented properly according to policies and procedures. 
Perform, schedule, coordinate and oversee emergency troubleshooting and repair on various HVAC, mechanical, utility systems, and lab and manufacturing equipment. (GxP and non-GxP). 
Assisting with the planning and execution of renovations within the clean suites. 
This work will be conducted during weekly production turnover periods which  necessitates the support of work on Friday and Saturdays through out the project  lifecycle

Qualifications 

Minimum of 2-5 years of Project/Facilities Engineering experience or experience working as a General Contractor, Construction Manager, or Subcontractor. 
Facilities background preferred.  
Prior Process Equipment, CAPEX & GMP experience 
Must have strong collaboration, communication, prioritization, and problem-solving skills. 
The position requires a highly motivated, independent, detail-oriented team player. Good organization, initiative, and a collaborative attitude is essential. 

Job Title: Facility Manager
Job Description: We are seeking a skilled and experienced Facility Manager to oversee the Facilities, Operations, and Maintenance (FOM) for a high-rise building campus in downtown Boston. The ideal candidate will have a strong HVAC refrigeration background with expertise in heat pumps, chillers (both water and air), boilers, and other systems and components. As the Facility Manager, you will be responsible for overseeing a team of employees with varying skills, driving KPI compliance, and managing day-to-day work orders to ensure the campus operates smoothly and efficiently.
Responsibilities:
• Oversee the day-to-day operations of the facility, including maintenance, repairs, and upgrades.
• Manage a team of union employees, providing leadership, direction, and support.
• Ensure compliance with all relevant regulations and safety standards.
• Develop and implement preventive maintenance programs to minimize downtime and maximize efficiency.
• Manage and prioritize work orders, ensuring timely completion and adherence to budget.
• Coordinate with vendors and contractors for specialized repairs and maintenance.
• Monitor and maintain equipment, ensuring optimal performance and longevity.
• Implement and manage KPIs to track performance and drive continuous improvement.
• Collaborate with other departments to support campus operations and initiatives.
• Provide regular reports and updates to senior management on facility performance and projects.
Qualifications:
• Bachelor's degree in Engineering, Facilities Management, or related field preferred.
• Minimum of 5 years of experience in facility management, preferably in a high-rise building or campus setting.
• Strong HVAC refrigeration background with expertise in heat pumps, chillers, boilers, and other systems.
• Experience managing a team of union employees, with excellent leadership and communication skills.
• Knowledge of relevant regulations and safety standards.
• Ability to prioritize and manage multiple tasks in a fast-paced environment.
• Strong analytical and problem-solving skills.
• Proficiency in MS Office and facility management software.
• Valid driver's license and reliable transportation.

Sequoia is seeking a Project Manager to perform work on various projects/programs with a business and technical scope. Project Managers lead a variety of different types of projects, including launching new products or services, transferring technology, and large-scale change efforts with systems and process. The ideal candidate must be a skilled team leader with strong negotiation and influencing skills, be able to work independently, handle multiple projects in parallel, and communicate effectively with all levels of the organization.

Responsibilities

Develop project tasks, deliverables, dependencies and resource requirements

Leverages interpersonal skills and good judgment to effectively navigate and drive project execution to meet or exceed project goals

Collaborate with cross-functional groups to create, execute and communicate overall project plans (scope, schedule, staffing plans, quality, risk management, budget, and procurement) and revise them appropriately to meet changing project needs and requirements

Identify needs for changes to plan and communicate them to the team and stakeholders to ensure program goals are in alignment with business objectives

Facilitate team meetings and workshops to meet project needs

Schedule and lead phase gate reviews with an executive approval committee

Identify and resolve or escalate program issues, facilitate trade off decisions, and remove obstacles

Continuously analyze and manage risks to enable successful project completion

Utilize appropriate tool and/or methodology to manage project, problem solve and document project information (RACI, SIPOC, etc.)

Define and optimize project management and development processes, methodologies, and tools to improve organizational efficiency and effectiveness

Qualifications

Bachelor's degree within an Engineering, Science or related field required

2-10+years of experience within Pharma/Biopharma, Medical Device, or Biotech industry

Project Management Professional (PMP) Certification preferred

Life sciences experience required

Strong technical project management or engineering experience preferred.

Experience using MS Project, Excel, and PowerPoint

Excellent communication and leadership skills as well as a strong work ethic

Experience within a cGMP and FDA regulated environment

Responsibilities 

The GxP Reliability Engineer will provide reliability engineering support for all facilities, utilities systems and equipment including analytical instrumentation, R&D lab support equipment and systems. 
This role will facilitate the deployment of Maintenance and Reliability Best Practices for new and existing equipment, facilities, and utilities at GxP sites including asset management, calibration, preventative maintenance, and spare parts. 
This resource will collaborate with stakeholders from Maintenance, Metrology, Engineering, Commissioning & Qualification, End users and Quality Assurance to complete deliverables in compliance with the established, procedurally driven programs including, but not limited to, calibration assessments, component criticality assessments, work package creation and modification, and spare parts through change request submission in the validated Computerized Maintenance Management System (CMMS). 
This individual will apply cGMP’s and Good Engineering Practices to Maintenance and Reliability program elements to minimize equipment downtime and appropriately support the needs of our stakeholders 
Inventory and Spare Parts support for GxP sites Maintain team program trackers and department metrics KPIs Identify and implement maintenance, calibration and spare parts improvements in the CMMS based on equipment trending and feedback to reliability 
Perform spare parts risk assessments to determine recommended stock levels to minimize the likelihood of unplanned part related downtime Execute calibration interval determination assessment forms for instruments 
Prepare and submit change requests for asset, maintenance, calibration and spare parts updates in the CMMS for asset on boarding 
Track completion of CMMS change requests and activation of CMMS attributes by system 

Qualifications 

Bachelor’s Degree in engineering or Facility Management or Equivalent experience Minimum of 2-10 years of experience in an engineering, facilities, equipment support role in a regulated environment Strong problem solving, technical, math and science skills 
Candidates must possess an aptitude for mechanical and electrical systems. How they operate, how they fail, ways to extend equipment reliability and usable life. 
Solid understanding of the application of Good Engineering Practices and Maintenance Best Practices and Reliability Engineering to a Facility Maintenance Program Foster change and innovation 
Understanding and application of technical principles, theories, and concepts in the field, GMP, ISO, GAMP, ANSI Experience with CMMS

Responsibilities: 

Manage contractors and equipment vendors to ensure all aspects of the projects are completed to specification, on schedule and according to budget. 
Manage changes to project scope ensuring original objectives are met in the appropriate timing. 
Identify and control project risks using appropriate risk management tools and engagement in contingency planning. 
Develop, manage, and maintain up-to-date Project Timelines inclusive of all critical milestones, key interdependencies, and resource constraints, applying appropriate project scheduling techniques. 
Prepare project estimates for design, equipment, installation, labor, materials, and other related costs. 
Coordinate closely with project stakeholders to effectively and efficiently communicate project logistics, impacts to site operations, delivery updates, risks, and solutions.  
Work with clients to source, review, and approve bid packages and proposals.  
Manage and oversee project contract work. Inspect or direct the inspection of work to ensure conformance to design drawings, specifications, schedules, and safety regulations.  
Ensure compliance with site and OSHA safety standards by reviewing JHA document and monitoring work to ensure the site 
Provide project management reports and presentations. Regularly communicate project status, including challenges and opportunities. 

Qualifications and Education: 

Bachelor’s degree in Chemical, Mechanical or other related Engineering or relevant field. 
Minimum of 2-10 years of project engineering experience in a Biopharmaceutical or Pharmaceutical manufacturing facility. 
Previous experience managing capital projects in excess of $100k dollars is preferred. 
Expert knowledge of Project Management methodologies and life cycle including ISPE good practice is preferred. 
Strong understanding of industrial and cGMP requirements, Engineering Life Cycle and associated quality systems. 
Experience facilitating meetings and establishing safe practices in a cGMP environment. 
Solid engineering capabilities related to reviewing and approving construction designs, equipment installation and specifications. 
Knowledge of electrical, mechanical, and environmental engineering, HVAC systems, and utilities. 
Knowledge of commissioning, qualification and validation and other regulatory compliance requirements.