Principal Plant Engineer - HVAC, CVRM

What You'll Do

Pre-Startup

During the plant start-up project you will be on the User Team and be accountable for establishing the site's foundational asset management program for HVAC-R and plant utility systems. In partnership with Project Engineering and the start-up project (user) team you will partner and collaborate with our partner site organizations (Engineering and MSAT, Quality, Supply Chain, Technical Development, Regulatory, CMO, Strategy) to provide expertise in project management and technical design, testing, qualification, validation, as well as all other activities related to design and start-up a new Drug Product Fill and Finish facility with a focused lens on HVAC/R systems such as air handling units, chillers, cooling towers hot water units and cold rooms. Initially, you will perform a mix of remote and onsite work (first at the General Planner's office, later at construction site/plant). You will transition to local full time on-site work once the site buildings are built and equipment delivered. Travel of up to 30% of the time is expected during the project phase.

Post-Startup

You will provide strategic and tactical leadership to ensure that the facility's HVAC systems operate with maximum reliability and in strict compliance with cGMP standards. You will drive optimal greenfield facility and operations design towards high manufacturing efficiency and quality in line with product and regulatory requirements. This includes inputs to the creation of master data and maintenance programs in SAP S4/HANA, our Computerized Maintenance Management Software. Oversee HVAC/R and Cleanroom Performance Testing contract services, as needed, to ensure maintenance needs are met and evaluate vendors or service contractor performance. This includes in the field troubleshooting, root cause analysis, and deviation, change control, and CAPA ownership. This will require strong collaboration with Automation, Validation, Calibration, Quality, and Manufacturing. You will own utility, HVAC/R, electrical, and control systems serving the manufacturing site and ensure a state of continuous compliance and audit readiness through the application of good engineering practices and troubleshooting methodologies. You will develop and optimize a reliability program for HVAC/R equipment and site infrastructure and proactively manage instrumentation/equipment obsolescence and improvement projects. You understand the bigger picture of the project and the CVRM disease area and how PT contributes to it. Works closely with the overall project team, the wider organisation and interdepartmental staff to meet department and company goals. Effectively partners with and influences stakeholders across the organization without formal authority, and drives technical decisions balancing product, site, and operations views. You will provide leadership for involved project teams and across the broader organisation. Provides training materials and training for people joining the organisation. Acts as a coach for colleagues with less experience and helps them develop skills/expertise. You will champion continuous improvement initiates to reduce planned and unplanned downtime. You will ensure that the Utility Systems are compliant from a regulatory standpoint and provide audit support as needed. You will develop and own the HEPA Program. You will be POC for HVAC related QMS Records. (Change Controls, Deviations, etc) You will be responsible for compliance with EPA Section 608 as applicable

Who You Are

• You have a bachelor's degree in engineering or life sciences and 8+ years of work experience in the pharmaceutical or related industry with direct experience in a cGMP regulated environment OR you have an associate's degree in engineering or life sciences and 10+ years of experience in the pharmaceutical or related industry with direct experience in a cGMP regulated environment.
• You have an ability to organize and solve complex, unique or unprecedented problems through the regular use of ingenuity and innovation; consistently demonstrating courage and drive to ensure optimal business results.
• You have updated knowledge of cGMP's, Health Authority regulations, and Quality Systems.
• You have experience with collaborators, regulatory agencies, and vendors inside and outside the company including coordination across organizational lines, including advising and influencing senior management on advanced technical matters.
• Utilizes an established network for technical issues within the company and the industry.
• You have strong organizational and interpersonal skills: can get things done in a way that optimizes results, strengthens internal and external relationships, and with consideration of resources. Coaches others.
• You have experience with process control and building automation systems.
• Experience with Propane, CO2, and Ammonia systems is preferred but not a requirement.
• Experience of Fire Suppression and monitoring systems
• Thorough understanding of Electrical Systems.

Work Environment/Safety Considerations

• Ability to work in an international/global environment.
• Domestic and international travel required. Travel up to 20% post-startup.
• May work in the clean room environment that requires gowning in the form of hospital scrubs, bunny suits, gloves, and safety boots.
• Potential to work near hazardous materials, chemicals, and equipment as per company safety procedures and guidelines.
• Demonstrated expertise / experience working safely on or near electrical equipment.
• Candidates must be flexible to work overtime and adjust working schedule beyond normal work week.
• Work schedule may be subject to change based on the phase of the project and/or commercial demand
• Relocation assistance is not available for this role.