Utility Engineer II/III
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 Utility Engineer II/III will provide engineering support for the facilities used for the GMP manufacturing of MacroGenics’ products and will engage in facility and utility application activities within MacroGenics and with outside partners (i.e. vendors). This individual will work with the Manufacturing team to design and scale-out manufacturing capability and support manufacturing operations, as well as improve existing manufacturing operations and facilities. This role will serve as a lead in the selection and implementation of new utility equipment and modifications to existing utility equipment in the GMP Manufacturing Facility and related systems. This individual will work closely with a cross functional team in order to meet the needs of the manufacturing facility.
Responsibilities and Job Duties
- Lead the design, implementation, and commissioning for new utility equipment and modifications to existing utility equipment and facilities within GMP Manufacturing while maintaining company quality and safety standards.
- Author and review protocols, standard operating procedures, and provide technical assessment and approval for engineering and process changes as well as documentation pertaining to qualification, and validation to meet regulatory requirements with respect to facility and utility systems.
- Work with industry /consultants to create design specifications, P&ID drawings, GA drawings, User Requirements, Functional Specifications and automation control strategies. Drive standardization within the department and within the company.
- Write and review technical documentation such as protocols and reports for FATs, SATs, and IQ/OQ/PQ testing.
- Ensure successful manufacturing production runs by assessing risk, setting preventative measures in place, investigating and troubleshooting utility equipment issues. Bring unresolved issues to supervisor and/or other team members.
- Participate in cross-functional teams to improve existing processes and drive change to increase efficiencies or minimize waste. Implement change management tactics to increase overall effectiveness of new processes and procedures
- Provide technical solutions to facility and utility equipment problems, develop reports that evaluate multiple solutions, share findings with appropriate personnel and make recommendations for problem resolution.
- Perform investigations of manufacturing deviations and anomalies related to failure of facility systems.
- Perform utility monitoring, utility capability, statistical analysis and quality engineering activities.
- 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 support with implementing new processes to the manufacturing area, assist with facility fit, lead any required utility equipment modifications, lead procurement activities for any needed new utility equipment. Support technology transfer
- Provide afterhours technical and troubleshooting support as needed
- Other duties as assigned
Education & Experience
Utility Engineer II
- Bachelor’s degree in Chemical, Biochemical or Mechanical Engineering, Biotechnology or equivalent and 2 years of related experience supporting manufacturing, preferably in the biotech or pharmaceutical industry
- High School Diploma (or equivalent) and 7 years of related experience supporting manufacturing, preferably in the biotech or pharmaceutical industry
Utility Engineer III
- Bachelor’s degree in Chemical, Biochemical or Mechanical Engineering, Biotechnology or equivalent and 5 years of related experience supporting manufacturing, preferably in the biotech or pharmaceutical industry
- High School Diploma (or equivalent) and 10 years of related experience supporting manufacturing, preferably in the biotech or pharmaceutical industry
Knowledge, Skills and Abilities
- Working knowledge of cGMP manufacturing and regulatory requirements for biologics and pharmaceuticals
- Ability to write technical reports and to develop data gathering schedules
- Capable of performing risk assessments
- Willingness to work with a “hands-on" approach in project construction, testing, and support
- Must have effective oral and written communication skills
- Excellent problem solving skills and ability to work in collaborative and independent work situations and environments with minimal supervision
- Computer skills: MS Office Suite, MS Project, and AutoCAD
- In-depth understanding and knowledge of Clean Utility Systems including; WFI generation and distribution, purified water generation and distribution, clean steam generation and distribution, HVAC for clean rooms, clean gas generation and distribution
- In-depth understanding and knowledge of Plant Utility Systems including; plant steam generation and distribution, chilled water generation and distribution, low and medium voltage electrical switchgear, diesel electric generators
- Capable of effectively negotiating contracts, bids, and change orders with vendors or contractors for equipment or systems
- Demonstrates a proficient understanding of equipment, instrumentation, and materials of construction to design, specify, procure, start-up, fully commission and troubleshoot equipment and systems
- Strong Knowledge of industry standards and guidelines, such as, ASME BPE, ISPE Baseline Guides and CFR’s
- Equipment qualification experience in a cGMP environment (IQ, OQ, PQ)
- Certified Quality Engineer, Six Sigma Green Belt, Six Sigma Black Belt or similar
- Experience performing discrete event simulation
- Experience in statistical analysis using JMP or Minitab
MacroGenics is proud to be an equal opportunity employer. Employment selection and related decisions are made without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, age, disability, protected veteran status, or any other characteristic protected by federal, state or local law. We are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please email email@example.com or call (301) 354-3566 and/or 711 for TTD/TTY service.
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