Job Abstract

Position Summary:

The Senior Facilities Engineer will provide engineering support and technical expertise for Local Exhaust Ventilation (LEV) systems, Refrigerant Systems (ODS), and Heating, Ventilation, and Air Conditioning (HVAC) in GMP, GxP, and non-GMP Environments. Responsible for the full life cycle for LEV systems including specification/ Design/ Installation/ Commissioning/ Service & Maintenance/ Inspection & Testing/ Routine use & User checks/ End of life testing and Decommissioning.

Major Duties and Responsibilities:

Pre-Occupation of the new facility
• Develop and maintain effective relationships with Key Customers to understand operational requirements.
• Work alongside the maintenance provider to ensure ongoing compliance with the LEVs & HVAC within the AstraZeneca laboratories/manufacturing/operations and to minimize the impact of testing and maintenance activities on research activities.
• Develop, alongside the project delivery, design, commissioning, and maintenance providers, handover acceptance criteria for the LEV and HVAC systems for the new Gaithersburg site.
• Coordinating and witnessing LEV and HVAC commissioning/IQ/OQ/PQ activities on site and providing assurance to the site leadership around the facility occupation
• Work alongside the maintenance provider to develop LEV and HVAC maintenance/metrology and testing strategies.
 

Post-Occupation of the new facility
• Responsible, in conjunction with a supply partner, for all engineering and SHE compliance in the area of LEV & HVAC.
• Accountable for the implementation of LEV and HVAC maintenance best practice techniques with the supply partner, including maintenance excellence processes.
• Responsible for verifying acceptable higher-risk local change control.
• Act as a works representative for more complex or larger capital investment projects.
• Jointly accountable for the delivery of the governance framework with our supply partners through an audit program.
• Ensure the service level agreement (SLA) is being met: all areas of the scope are being delivered, and response times are being met. Ensure that complaints and feedback are being acted on.
• Ensure the technical standards for the service are being followed.
• Ensure the supplier is protecting the health and safety of all personnel in the workplace by compliance with our standards.

• All projects will be aligned with the sustainability and environmental strategy for the Gaithersburg campus

• Properly plan each project to ensure that project-specific strategies are developed, implemented, communicated, and constructed

• Utilize Project Planning principles to define prioritized objectives, document planning assumptions and key decisions  regarding alternatives considered,  facilitate communication  among stakeholders, and guide project delivery

• Utilize Engineering knowledge and tools to ensure equipment is reliable and maintainable.

• Define the scope of work that supports the business goals, obtaining approval from the Project Sponsor

• Create clear boundaries and definitions of the facilities,  processes, and systems to be delivered

• Mitigate risk but utilizing a systematic approach to reduce the project's exposure to risk by identifying, understanding, analyzing, and managing uncertainty in a project

• Ensure the project construction site both within and around the affected area is effectively controlled to reduce the risk of injury

• Utilize detailed and site-specific policies and procedures, job hazard assessments and hazard communications, personal protective equipment (PPE), and staff training to minimize and control all safety risks

• Ability to multitask and manage multiple projects concurrently.

• Maintain a current and thorough understanding of all utility and manufacturing equipment typically found in Pharmaceutical and Biotechnology Utility Plants, R&D Labs, Pilot Plants, and cGMP manufacturing environments.

• Excellent written and verbal communication skills.

• Proficient in computer skills and MS Office application suite.

• Experience in maintenance trades and knowledge of building codes.

• Available 24/7 to direct and coordinate emergency issues.

• Responsible for Change Controls, Deviations, and SOPs in responsible areas of control.

• Review design and construction documents for new site projects. Familiarity with all construction and engineering terms and processes.

• Manage campus compliance with EPA, MDE, and MCDEP regulations and AstraZeneca’s Global Standard, regarding selecting, handling, and documenting the use of ozone-depleting substances (ODS), fluorinated gases compounds (F-Gases), and other refrigerants.

Education:

Minimum Requirements:

• 4-year degree in Mechanical or Chemical Engineering Degree and 5 years of experience supporting facilities engineering within a regulated or cGMP environment.

• 2 years or more in LEV and Control System design

• 2 years or more in HVAC, Refrigeration and Control System design

Preferred Requirements:

• Master’s degree in Engineering. 

• P601 Qualification or OSHA Part 1910 and 1926 knowledge.

• PMP Certification

• 2-5 years of Project Management experience

Special Skills/Abilities:

• Technical Knowledge: Pharmaceutical systems, industrial utilities, process equipment, Refrigeration equipment, GXP, HVAC, General Construction Practices, Maintenance Software, Building Management Systems

• Language Skills:  Ability to read, analyze, and interpret documents such as financial reports, safety rules, operating and maintenance instructions, procedure manuals, technical procedures, or governmental regulations. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to write reports, business correspondence, and procedure policies. Ability to effectively present information and respond to questions from groups of managers, clients, and customers.

• Mathematical Skills:  Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.

• Reasoning Ability:  Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results. Ability to apply common sense understanding to carry out detailed but uninvolved written or oral instructions.

• Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to

interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

• Computer Skills:  Outlook, Internet Explorer, SAP, Capability to Utilize Various Programs Developed for day-to-day operations, Specialty Maintenance PM Software, MS Office Programs (Excel, Word, Project, etc.)

Our Gaithersburg, Maryland facility creates life-changing medicines for people around the world. This campus employs more than 3,500 experts in our field and is only a short drive from Washington, DC. This modern and vibrant scientific campus is the home of R&D and Oncology in the US. Here, we play host to some of the most cutting-edge technology and lab spaces, all designed to inspire collaboration and cross-functional science. We believe employees benefit from being challenged and inspired at work. We are dedicated to creating a culture of inclusion and collaboration.

The Gaithersburg site offers a variety of amenities to help boost productivity and help keep our employees happy and healthy. This includes a fitness center, employee healthcare clinic, electric vehicle charging stations, dry cleaning, full-service cafeteria and copy center. This is where you’ll find newly-designed, activity-based work spaces to suit a variety of working styles while increasing collaboration between teams.

Date Posted

Closing Date