MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies. Our team of 300+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer as well as various autoimmune disorders and infectious diseases. Our products and platforms have attracted multiple partnerships with leading pharmaceutical companies around the globe.
The Company considers its employees to be its most valuable asset and we are committed to providing opportunities for individuals to learn and grow as a means to further their professional development. MacroGenics' corporate culture promotes an atmosphere of innovation, open communication and teamwork where employees can see firsthand how they contribute to the success of the organization.
Summary of Position
The Senior Automation Engineer is responsible for executing automation tasks related to design and implementation of a Process Control System, Building Automation System and system integration. The position will carry out scope definition /clarification exercises to properly and completely characterize automation requirements and be responsible for design, specifications, budgeting, scheduling, resource management, implementation, and commissioning. This position requires an in-depth knowledge of biotech/pharmaceutical process equipment automation, historian data collection, electronic batch records, general working GMP knowledge of biotech/pharmaceutical manufacturing facilities, and all major utilities.
Responsibilities and Job Duties
- Lead automation work for the multiple small functional projects and/or a large capital/functional project. Engineer and manage process equipment/control systems reliability improvements, optimization, upgrades as well as implementation of new equipment control systems from the concept to commissioning and validation.
- Work with industry experts/consultants to create automation specifications and standards, electrical drawings, network drawings, User Requirements, Functional Specifications and automation control strategies. Drive standardization within the department and within the company.
- Assess existing equipment and control systems in the various manufacturing area and determine the required changes to meet the design, reliability and requirements.
- Provide hands-on technical support, diagnostics and troubleshooting functions to manufacturing operations.
- System owner for plant wide automation systems, technical owner and administrator for process and utility equipment automation systems.
- Perform data backups, perform server maintenance activities, and monitor performance of automation systems to proactively detect potential failures.
- Develop operational and maintenance SOPs for the automation systems.
- Develop system lifecycle approach for automation systems and maintain necessary documentation (Functional Specifications, Detailed Specifications, Instrumentation and Control Drawings).
- Participate in cross-functional teams to implement change and improve existing processes.
- Perform investigations of manufacturing deviations and anomalies related to failure of automation systems and make necessary changes.
- Prepare new and revise current drawings on vendor-provided documents and in-house redlines.
- Review drawings and designs for adherence to established specifications and standards.
- Provide afterhours technical and troubleshooting support as needed.
Education & Credentials
Bachelors in Chemical, Electrical or Computer Engineering, Life Sciences or equivalent
- Minimum of 8years of related experience
- Experience in Distributed Control System implementation, especially DeltaV
- Experienced in leading the design, programming, start-up, operation and troubleshooting of automation systems including PLC and DCS systems
Knowledge, Skills and Abilities
- Solid understanding of cGMPs and engineering systems
- Familiarity with industry standards for batch control systems, software development life cycle methodologies, 21 CFR Part 11, and GAMP
- Strong knowledge of industry standards and guidelines, such as, ASME BPE, ISPE Baseline Guides and CFRs
- Ability to write technical reports and to develop data gathering schedules
- Knowledge of current standards of control system platforms and computer validation
- Demonstrates a proficient understanding of automation systems, instrumentation, and equipment to design, specify, procure, start-up, fully commission and troubleshoot automation systems
- Capable of performing risk assessments
- Capable of effectively negotiating contracts, bids, and change orders with vendors or contractors for automation systems
- Ability to work with suppliers and owners on technical specifications and procurement details
- Willingness to work with a “hands-on" approach in project construction, testing, and support
- Must have effective oral and written communication skills
- Working knowledge of various automation platforms including DeltaV, Siemens Building Automation Systems, and Allen-Bradley PLC’s
- Computer skills: MS Office Suite, MS Project, Networks, Servers, Thin Clients
- Working knowledge of GE Unicorn, Siemens PLC’s, and Historians including OSIsoft PI
- Working knowledge of BUS communication technologies such as DeviceNet and Modbus
- Working knowledge of OPC communication
- Certified Quality Engineer, Six Sigma Green Belt, Six SigmaBlack Belt or similar is a plus