Clean Utilities Engineer

Job title: Clean Utilities Engineer

Location: Swiftwater, PA

Note: Candidates must be available 40 hours per week, Monday-Friday

About the Job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

Our Team/ Overview

The Clean Utilities Engineer will be responsible for leading design and managing clean and site utility Tier III projects at the SWR site, along with routine M&S process support.  This position will be responsible for working with other Engineering and Project Management teams as a Subject Matter Expert (SME) for Clean utilities.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?​

Main Accountabilities:

The Clean Utilities Engineer is responsible for successful delivery of Clean and Plant Utilities portions of Tier III and Infrastructure projects (approx. $0M to $5M  value), helping to manage contractors and set site design standards in accordance with Sanofi Global standards and Swiftwater site norms.  Additionally, responsibilities include troubleshooting issues of concern with GMP and Plant Utility Systems and associated equipment.  Efforts include walkdowns of equipment and piping systems (GEMBA) and assistance with deviations and change controls as required.  The Clean Utilities engineer will be responsible for managing design, cost, schedule, construction, safety, quality, commissioning, qualification and validation activities on both projects and site process support for applicable scope in an effective manner in accordance with Sanofi Project Management policies & procedures to meet committed project objectives. Scope includes projects involving both new, and modifications to existing equipment, process, utilities, buildings and infrastructure systems, site audit support, and a key input to Site Master Planning.

Main Responsibilities:

• Provide input and engineering to support decision making processes with site leadership team and central process function. 

• Establish strategic relationships with key stakeholders. Support Site Leadership Team (SLT) and the Compelling Business Needs (CBNs) by ensuring alignment of workloads with company priorities.  Frequent collaboration/presentation with senior level SWR and Global Sanofi Management is required.  Act as the liaison into regional project execution programs and support with resourcing and expertise when requested.

• Advising on strategies to ensure all utilities engineering activities comply with industry regulations and standards

• Implementing process improvements to enhance efficiency, safety, and quality within the engineering and maintenance groups

• Emphasis on implementation of projects in a safe and GMP compliant manner. Meet all HSE training requirements, and implement HSE procedures (Safe Plan of Actions, Permits, Pre-Startup Safety Review, HSE checklist, etc.) on all projects. Assure compliance with Quality requirements as defined by applicable Sanofi Quality Standards, site procedures, and by Change Control requirements.

• Provide input for selection and management of external contractors and suppliers to ensure they meet the company’s standards and requirements.

• The Clean Utilities Engineer will be expected to understand and use key Sanofi systems including electronic document management tools, Qualipso, Bluecielo, etc., and must have experience supervising engineering design, conducting structured project reviews, supervising construction activities, managing cost and schedule, tracking progress, planning and coordinating C&Q activities, coordinating with maintenance for calibration and turnover activities, managing CAD and technical documentation turnover, and coordinating with other stakeholders and functions during execution.

• The Clean Utilities Engineer must be comfortable working in GMP Process and industrial settings.  Providing “hands-on” inspections of equipment and piping systems and providing engineering insight into the operations and design of these systems.

• The Clean Utilities Engineer will be responsible for working with contractors and other team members to assure that all systems, in the scope of responsibility, are constructed in accordance with relevant specifications and Sanofi standards, and that all relevant turnover documentation is supplied in a compliant and timely manner.  Startup and commissioning of new or modified systems is essential as well as working with the C&Q team members to assure that systems can be qualified per Sanofi and cGMP standards.

Related KPIs & Metrics:

• HSE performance (Injury Rates, Near Misses, Potential Serious Injuries (PSI))

• On time, on budget delivery of representative systems while adhering to strict quality and regulatory standards and specifications.

• Represent Clean Utilities systems during inspections and audits.

• Impact on Business Outcomes of M&S

About You

Education & Experience & Certifications:

• Excellent leadership, communication, and cross-functional collaboration skills

• Technical Expertise (In-depth knowledge of engineering & maintenance principles on pharmaceutical manufacturing processes) 

• Technical knowledge of process equipment, understanding of automated mechanical systems and the ability to create and interpret technical documentation.

• Regulatory Knowledge (Familiarity with pharmaceutical industry regulations, including GMP, FDA, & ISO standards) 

• Problem-Solving (Excellent analytical and problem-solving skills to address technical issues.)

• Minimum B.S., Engineering Degree and/or Equivalent Science/Technical Degree with experience relevant to life sciences and/or vaccines manufacturing.

• Minimum 5-10 years’ experience in engineering & maintenance of Clean Utilities systems, supporting small to medium capital projects.  Demonstrated experience with GMP requirements, engineering design, construction, project controls (including cost control and scheduling), commissioning, qualification and validation activities.

Physical Requirements & Special Working Conditions:

• N/A

Key Involvement in Decision-Making Process:

Key Roles (D,A,I)

• Capital Project Approvals (A)

• Project < 5M€ (D) and Project > 5M€ (A)

• Regulatory Compliance Strategies (A)

• Process Improvement Initiatives (A)

• Vendor Selection and Management (D)

Local specificities

Additional Accountabilities:

• N/A

Disclaimer

The above information was designed to indicate the general nature and level of work performed by employees with this job description. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Requirements are subject to possible modification to reasonably accommodate qualified individuals with disabilities. This document does not create an employment contract, implied or otherwise, other than an “at will” employment relationship.

Why Choose Us?

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants
will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic
partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability
for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or
any other characteristic protected by law.​

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