Associate Engineer

AstraZeneca • Gaithersburg, MD

1d • $67,935 - $101,903 • Onsite

About The Position

Do you have a passion for Science? Would you like to apply your expertise to impact a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you! At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person. About AstraZeneca in Gaithersburg, MD: Our Gaithersburg, Maryland facility creates life-changing medicines for people around the world. This campus employs more than 3,500 authorities 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 ground breaking technology and lab spaces, all designed to inspire collaboration and multi-functional science. We believe employees benefit from being challenged and encouragedred at work. We are dedicated to crafting a culture of inclusion and teamwork. The Gaithersburg site offers a variety of amenities to help boost efficiency 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 teamwork between teams. Summary of the group: This position will be led by an Associate Director Engineer within the Engineering Technical Services group of Manufacturing Sciences within Bio-Process Development. The position is responsible for ensuring the reliability of process systems and equipment for multiple manufacturing and/or development areas at AstraZeneca’s Gaithersburg facilities, provides technical support and mentorship to colleagues in area of expertise, applying developed solutions and supporting performance improvement projects while adhering to local best practice, safety and compliance standards. The Engineer will be supporting the manufacturing of monoclonal antibodies, viral campaigns, antibody drug conjugation, and the cell therapy technology. Accountabilities: You will provide on-the-floor manufacturing support for an assigned manufacturing area, monitor equipment performance and identify issues. You will develop technical solutions for equipment problems, perform solving, maintenance, and process performance optimization. You will also support shutdown and return to service activities. As an authority (SME) for Biotech manufacturing equipment and systems, you will provide technical support to team members and other engineers. You will use existing knowledge and experience to resolve daily operational problems and coordinate maintenance activities with Facilities and service contracts with outside vendors. You will write, track, and perform SAP work orders, build and revise Preventative Maintenance plans, provide recommendations for continuous improvement activities, conduct root cause analysis and support new product introduction. You will participate in Engineering function activities to ensure priorities are met and projects are delivered as planned. You will lead and participate in projects of varying sizes and complexity, resolve process requirements and support the design, installation, and commissioning of new processes and equipment. You will perform quality/safety investigations and risk evaluations, own and drive Quality and Safety Corrective and Preventive Actions (CAPAs), independently perform Good Manufacturing Practice (GMP) change control activities. You will write and review both current Good Manufacturing Practice (cGMP) and non-GMP documentation, develop and review Standard Operating Procedures (SOPs), validation protocols, user requirements, specifications, Job Hazard Analyses (JHAs), drawings, work instructions, and reports.

Requirements

• BS/BA Engineering degree preferred
• Minimum 0-1 yrs. experience with a bachelor's degree
• Good troubleshooting and problem-solving skills
• Strong oral and written communication skills

Nice To Haves

• Ability to work independently (Required for Engineer)
• Demonstrated technical skills in supporting GMP manufacturing (Required for Engineer)
• Strong interpersonal skills
• Hands-on mechanical, electrical, and/or electronic skills
• Experience with operating and/or maintaining biotech manufacturing equipment
• Project management experience and GMP organizational change experience
• Demonstrated ability to work effectively within a large network/matrix organization

Responsibilities

• provide on-the-floor manufacturing support for an assigned manufacturing area, monitor equipment performance and identify issues
• develop technical solutions for equipment problems, perform solving, maintenance, and process performance optimization
• support shutdown and return to service activities
• provide technical support to team members and other engineers
• resolve daily operational problems and coordinate maintenance activities with Facilities and service contracts with outside vendors
• write, track, and perform SAP work orders, build and revise Preventative Maintenance plans, provide recommendations for continuous improvement activities, conduct root cause analysis and support new product introduction
• participate in Engineering function activities to ensure priorities are met and projects are delivered as planned
• lead and participate in projects of varying sizes and complexity, resolve process requirements and support the design, installation, and commissioning of new processes and equipment
• perform quality/safety investigations and risk evaluations, own and drive Quality and Safety Corrective and Preventive Actions (CAPAs), independently perform Good Manufacturing Practice (GMP) change control activities
• write and review both current Good Manufacturing Practice (cGMP) and non-GMP documentation, develop and review Standard Operating Procedures (SOPs), validation protocols, user requirements, specifications, Job Hazard Analyses (JHAs), drawings, work instructions, and reports

Benefits

• fitness center
• employee healthcare clinic
• electric vehicle charging stations
• dry cleaning
• full-service cafeteria
• copy center
• qualified retirement program [401(k) plan]
• paid vacation and holidays
• paid leaves
• health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level