Heating, Ventilation & Air Conditioning (HVAC) Subject Matter Expert

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

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Position Reporting to the AD Engineering Technical Services, the HVAC Engineering SME will be the HVAC System Owner for GMP and Non GMP HVAC Systems. The SME will provide engineering support or backfill for Utilities SMEs for specific assigned plant (Black or Clean) Utility infrastructure, systems, and equipment across the entire site to ensure a safe working environment for colleagues and a sustainable & reliable plant to ensure continuity of supply of medicines for our patients.

The HVAC SME will be accountable for the delivery of oversight of Technical Standards across the systems under their ownership, including ownership of Engineering Specifications, drive standards and regulatory compliance and align with Global Eng Standards on projects. Ensure the Operations & Maintenance teams and service providers working on the site systems have the right competency development and assessment programs and ensure compliance to Engineering procedures onsite.

As the drivers of technical standards on Systems, the HVAC Engineering SME will need to be outward looking, benchmarking with other sites inside and outside the BMS network, visiting Industry conferences, contributing to industry standards development through membership of NSAI technical committees or similar industry forums, driving engagement with Global Engineering. The HVAC & Utilities Engineering SMEs will also focus on complying with good engineering practices, company policies, regulations, and codes. As part of the Engineering Technical Services team, the HVAC & Utilities Engineering SMEs will ensure the wider engineering objectives support the needs of the site.

Key Responsibilities:

• Ensuring all the systems are in compliance with all Regulatory requirements including Quality (cGDP/GMP’s), EHS, European directives, Global Engineering, design & construction directives, requirements & procedures, as well as all Local Regulatory requirements.

• Developing Project Requirements Documents (PRD’s) and User Requirements Specs (URS) for new equipment and modifications to existing equipment and systems from concept through supporting installation with the collaboration of stakeholders.

• Point Person for the BMS Project Team as regards HVAC Systems. Participate in system design reviews, equipment selection & Hazops to ensure the design and Project deliverables meet BMS requirements, site Engineering specifications and SOP’s.

• Responsible to evaluate all the drawings and technical data required for HVAC systems to be handed over to BMS site Engineering doc control for implementation of the project.

• Responsible for the review / approval of Bid-Packages for the procuring of HVAC equipment and systems for In-house and capital projects.

• Responsibilities include:

  • Advising A&E and CM on BMS expectations for bid package contents,
  • Assuring that A/E deliverables truly capture existing conditions and site particularities.
  • Reviewing A&E deliverables,
  • Assuring Bid Package Quality and Timely completion.
  • Assisting CM during Pre-Bid Meeting. Evaluation of Construction Bids.
  • Approval of the proposed vendor list
  • Responsible for the development and implementation of the Special Systems strategy
  • Overall Responsibility for the assigned Utilities system Design of the Facility

• Reviews and approves commissioning protocols associated with HVAC systems and area of expertise.

• Involves BMS Site Engineering teams / SMEs as needed to assure alignment with best practices, equipment platforms, site specifications and standards.

• Involves Global engineering as required for critical design reviews and vendor technical discussions.

• Assist the Project Manager, Engineering personnel & project SMEs in the resolution of discipline related technical questions, RFIs, Client request, Vendor Submittals, etc.

• Owner of the site Engineering specifications as they relate to the HVAC systems. Responsible for the ongoing update and approval for any proposed changes or deviations from the specs to ensure the specs are current and contain all key technical information.

• Works closely with the CM, project and BMS teams to develop a baseline schedule which supports project completion date.

• Supports CM and CQV team on troubleshooting during start-up / commissioning activities.

• Developing, reviewing and auditing the CMMS data, calibration data sheets, Spare parts requirements, PMs, PdMs, job plans etc. to ensure that all maintenance schedules are designed to deliver compliant, cost effective, efficient reliability-based maintenance programs maximising uptime.

• Performing and facilitating root-cause failure analysis (Cause Mapping) on chronic/critical/high impact failures.

• Ensure the O&M teams have the appropriate training and documentation in place for the smooth operation and fast recovery of the HVAC systems i.e., the appropriate SOPs’, WI’s, OJT’s & eLearning’s are in place and updated to reflect system operational knowledge.

• Using the CMMS, carry out periodic review and audit of maintenance reports from Vendors and contractors, develop action plans etc. to address any issues. Raise the issues found with the relevant maintenance teams to ensure the issues are appropriately addressed with CMs/PMs/Pdm etc.

• As HVAC system owner support all compliance - complete risk assessments, RCA investigations, identify appropriate CAPAs etc. to ensure no re-occurrence of issues.

• As Equipment and System owner, be the owner (Final approver) of any change controls associated with the HVAC systems. Final approval of all SLA amendments or initial implementation of SLAs on HVAC systems.

• Provide subject matter expertise and technical support for GMP-critical HVAC systems, including sterility isolators, downflow booths, biosafety cabinets, walk-in incubators, cold rooms, and laminar airflow units, ensuring ongoing compliance with applicable regulatory standards.

• Technical support for non-GMP systems including CRAC units, heat recovery systems, humidifiers, dehumidifiers, and tempered glycol.

• Serve as the primary HVAC SME for all GxP assessments relating to cross-contamination control, aseptic processing environments, and environmental monitoring (EM) investigations, supporting regulatory compliance and risk mitigation.

• Actively contribute to the site's decarbonisation strategy by identifying and implementing energy efficiency improvements across HVAC systems, supporting BMS sustainability goals and carbon reduction targets.

• Partners with Reliability team to support the procurement of spare parts, Final approver of parts change management.

• Engineering owner for the automated engineering systems e.g., BAS, WWTP SCADA, Standalone Black box Utility systems, etc.

• Supporting audits as the System SME as required.

• Establishing high performance standards including development of appropriate metrics to track running costs, performance, efficiency, uptime etc. for all equipment and systems.

• Developing budget estimates for any improvements / modifications / projects related to assigned utility equipment. All improvement works and modifications must be done with sustainability in design and carbon / energy reduction at the forefront.

• Developing/implementing new capital project scopes, performing project management for equipment related modification projects on assigned systems as required.

• Developing/implementing an assessment process to ensure the Operations & Maintenance teams, Reliability personnel and service providers working on the site HVAC & Utilities have the right competency to work on these systems.

• Succession planning via knowledge transfer to the appropriate Reliability & Maintenance Engineering personnel. Ensure all key technical data is captured in relevant SOP’s, WI & eLearning training modules.

• Support the reliability team in running Solvace boards & forums to capture the overall status of the GMP & Non GMP HVAC systems. Ensure issues identified with risk to business are escalated through the engineering tier process.

• Developing/implementing a system(s) to control the master settings & parameters for all HVAC systems.

• Be an advocate of continuous improvement.

Required Competencies and Skills:

• Must be a team player prepared to lead, work effectively and efficiently in a team-based environment.

• Proven ability to prioritize maintenance activities and resources to achieve a safe and reliable site with maximum uptime.

• Proven ability to provide solutions that reflect understanding of business objectives and cost implications.

• Experience dealing with external stakeholders including EPA, HSA, Insurers, Fire Authority, Global EHS and Engineering teams, Regulatory Inspectors, and Internal QA Auditors.

• Detailed knowledge and experience in operating and design of GMP & Non GMP HVAC & Utility equipment and systems.

• Detailed knowledge and experience in the pharmaceutical/ biopharmaceutical industry, with in-depth knowledge of regulatory requirements (safety and quality).

• Experience in troubleshooting and providing SME support for HVAC & Utilities Systems in a GMP Environment.

• Experience maintaining complex equipment in fast paced environment.

• Demonstrated experience and ability to effectively manage stakeholders.

• Excellent communication skills and the ability to influence others.

• Problem solver with a focus on achievement of overall project goals.

• Extensive knowledge in the Operation and Maintenance of systems in the pharmaceutical industry using a CMMS.

Required Qualifications and Experience:

• The candidate will hold a minimum of a Level 8 qualification in a Mechanical engineering discipline.

• At least 8 years’ experience working in pharmaceutical manufacturing facilities in a maintenance engineering or utilities role in a similar scale pharmaceutical manufacturing site with 24x7 operations.

• Extensive knowledge of Critical Utilities systems (Black & Clean Utilities) in a pharmaceutical facility such as HVAC, Coldrooms, Freezers, Boilers, steam generation & distribution, chillers, cooling towers, Fire main, Fire Suppression, softened water, RO, WFI, Chemical dosing, WWTP, etc.

• Professional Member of Engineering organization such as IEI or IET with CEng status or on route to become chartered.

• Excellent understanding of Engineering requirements with legal basis including Building Regulations for HVAC, EU Directives, (ATEX, Pressure, Machinery, etc.), Irish Legislation, Life Safety, etc.

• Excellent understanding of Codes and standards for design of new utilities systems or alterations to existing HVAC & Utilities systems.

• Proven success working well in a team environment with flexibility to react to changing business needs.

• Preferably maintenance experience in both Biologics Manufacturing Operations, HVAC & Critical Utilities.

Why you should apply

• You will help patients in their fight against serious diseases
• You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.
• You’ll get a competitive salary and a great benefits package including an annual bonus, pension contribution, family medical allowance, 27 days of annual leave, life assurance and on-site gym

#LI-Hybrid

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

Supporting People with Disabilities BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

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R1605687 : Heating, Ventilation & Air Conditioning (HVAC) Subject Matter Expert