The Sr Mechanical Engineer is primarily responsible for the oversight and troubleshooting support of mechanical and utility systems in the facility. These systems can include HVAC, Cold Room/Freezers and Clean/Black utilities. They would also be responsible for supporting Capital Project teams with design reviews and providing inputs with equipment selection based on performance requirements. The Engineer will serve as a lead for engineering operations, facilitating collaboration between facilities, manufacturing, automation, quality assurance, validation and project engineering. This individual will work closely with a cross-functional team to meet the needs of the groups they support.
- Responsible for providing support for existing and new systems. Review and make recommendations to management for utility equipment replacement and/or reliability upgrades as part of the life cycle improvement process and continuous improvement initiative planning.
- Responsible for providing engineering expertise to support the design reviews, installation, commissioning, validation and operation of mechanical systems.
- Responsible for cGMP facility design and improvement projects (Cleanrooms, Labs, ISO classes, HVAC, Refrigeration, Freezers, Environmental rooms, etc). Play an essential leadership role in the operation and troubleshooting of the utility and HVAC systems.
- Serve as the subject matter expert. Provides technical expertise for all phases associated with utility/facility systems.
- Perform regular ﬁeld walk-through tours and inspections and initiate any procedures necessary to resolve problems.
- Support the planning and execution of activities by working in cross-functional teams. Assist in driving projects to completion to meet timeline and budget objectives.
- Continuously stay current with assigned SOPs and keep an up to date training ﬁle ensuring compliance with all applicable Standard Operating Procedures.
- Collect, analyze and report data for use by the Facilities and Finance departments to ensure reliable, cost eﬀective operation. Periodically review and assist with Building Air Balance Testing.
- Responsible for change controls, CAPAs, risk assessments, Safety and support of Regulatory Agency Audits. Provide guidance for support personnel and helps drive development of PM programs.
- Prepares User Requirements Speciﬁcations (URS), Risk Assessments, Safety Assessments associated with the utilities and HVAC systems.
- Participate in validation activities including review of IQ/OQ protocols, executions and summary reports. Lead commissioning eﬀorts to ensure validations are successful.
- Participate in the development and implementation of procedural Standard Operating Procedures (SOPs), technical speciﬁcations (Design/Functional/System) and updating P&IDs.
- Manage small-scale capital projects, creating scope of work, justiﬁcation, cost estimates and implementing purchase order requisitions.
- Provide support to the Capital Projects Team assisting with equipment submittal reviews, MEP speciﬁcation and drawing reviews, FAT’s/SAT’s, turnover package reviews ensuring that the documentation is accurate and complete and meets speciﬁcations.
- Coordinate with site departments to schedule utility system shutdowns, tie-ins and system startup. Assist with developing predictive and preventative maintenance program for utility and HVAC systems.
- Demonstrate continuous improvement with respect to increasing job knowledge and proﬁciency related to engineering in the biopharmaceutical industry, as well as technical understanding/problem solving capability. Completes any other duties/responsibilities assigned by senior management
- The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reﬂects management’s assignment of essential functions.
MINIMUM EDUCATION, EXPERIENCE, SKILLS
- Bachelor’s Degree in Mechanical Engineering preferred or B.S. degree in an Engineering related ﬁeld, with 8+ years of experience in an engineering role in support of a large industrial, pharmaceutical, biotechnology or FDA regulated facility.
- Experience with architectural, MEP and P&ID drawings preferably in the pharmaceutical industry.
- Be knowledgeable with respect to HVAC systems (air handling units, return fans, exhaust fans, air terminal devices, diﬀusers, grilles, refrigeration cycles and other air moving processes).
- Must have experience with executing test protocols for Freezer Coolers, Incubators, Clean Room Environments and HVAC Equipment in a FDA Regulated Environments.
- Knowledge of biopharmaceutical process operation and process control, clean utility and mechanical systems (pumps, valves, materials) as foundation for troubleshooting, design and equipment evaluation. Knowledge of clean room design/requirements. Working knowledge of pharmaceutical process sanitary connections, valves and supply loops.
- Working knowledge of Process Control and Instrumentation for facility control systems. Basic knowledge of programmable logic controllers (PLCs), instrumentation (e.g., ﬂow, pressure, temperature, level) and controls is required.
- Must possess basic knowledge of core principles in various engineering disciplines (ﬂuid mechanics, heat transfer, thermodynamics etc.)
- Knowledge & experience in the design, implementation, operations and maintenance of clean utility systems, as well as working in a regulated environment (FDA, cGMP, OSHA).
- Strong knowledge of industry standards and guidelines such as ASME BPE, ISPE Baseline Guides, ISO standards and CFR’s.
- Experience with Quality Management and Change Control Systems.