Principal Plant Engineer - HVAC, CVRM

F. Hoffmann-La Roche AG; Holly Springs (MS); On-site; USD 95,000 - 177,000; Full time

Job summary

Genentech is seeking a Principal Plant Engineer to serve as the site’s top technical SME for HVAC/R, plant utilities, and end-to-end asset management during a major greenfield start-up in Holly Springs. You will lead project design, qualification, testing, and validation in collaboration with MSAT, Quality, and Regulatory teams.

The role requires 8+ years in pharma/cGMP contexts (or 10+ with an associate degree), strong knowledge of building automation, environmental control, and chemical

Qualifications

• Bachelor's degree in engineering or life sciences with 8+ years in pharma or related industry in a cGMP environment OR an associate's degree with 10+ years' experience
• Knowledge of cGMPs, regulatory expectations, and Quality Systems; ability to influence senior management on technical matters
• Experience with automation, validation, calibration, QA, and cross-functional collaboration

Responsibilities

• Lead the site's HVAC/R asset management program during start-up and ongoing operations
• Partner with engineering, MSAT, Quality, Supply Chain and Regulatory teams to design, test, qualify, and validate HVAC/R and plant utility systems
• Develop and own reliability programs for HVAC/R equipment and site infrastructure while ensuring regulatory compliance

Skills

HVAC/R systems

Asset management

Project management

cGMP compliance

SAP S4/HANA

Validation & testing

Vendors & contracts

Education

Bachelor's degree in engineering or life sciences

Associate's degree in engineering or life sciences

Tools

Propane/CO2/Ammonia systems

Job description

Welcome to Holly Springs, North Carolina- home to Roche/Genentech's largest-ever investment: a $2B greenfield start-up where next-generation technology, high-performing teams and Operational Excellence converge to create the global standard for high-volume, highly-efficient Drug Product manufacturing. The facility's core is defined by Innovation - leveraging advanced automation, robotics, digital tools, real-time data analytics, and simple, streamlined processes to produce the highest quality medicines. This plant meets today’s demand for CVRM (Cardiovascular, Renal, and Metabolism) medicines and is scalable to grow with the portfolio, which focuses on next-generation metabolic medicines specifically targeting the global obesity epidemic and Type 2 diabetes. This is a fast-paced, entrepreneurial environment with a high-level of accountability, with planned launch in 2028. Are you a problem-solver and change-agent who thrives in a Team environment, eager to tackle the most complex manufacturing challenges? If so, this is a once-in-a-lifetime opportunity to launch a state-of-the-art facility from the ground-up and shape the culture of our organization for the next generation. Join us in Holly Springs, where you won't just build a plant-you will build the future of medicine.

The Opportunity

We're seeking a highly skilled and experienced Principal Plant Engineer who will be the site’s highest-level technical subject matter expert (SM) for the site’s HVAC/R program, including end-to-end asset management for all HVAC, refrigeration, and cold/warm room systems and plant utilities.

What You’ll Do

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.

The expected salary range for this position based on the primary location for this position of Holly Springs, North Carolina is $95,200 - $176,800. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.

Link to Benefits

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.

Who We Are

Genentech, a member of the Roche group and founder of the biotechnology industry, is dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. To solve the world's most complex health challenges, we ask bigger questions that challenge our industry and the boundaries of science to transform society. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis. The next step is yours.