Utility Engineer III
Gaithersburg, MD 20877
Utility Engineer III
The Utility Engineer III will provide engineering support for the facilities used for the GMP manufacturing of pharmaceutical products and will engage in facility and utility application activities with outside 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 support of existing utility equipment, selection and implementation of new utility equipment and/or modifications to existing utility equipment in the manufacturing facilities and central warehouse site. 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 of new utility equipment and modifications to existing utility equipment and facilities 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.
- Manage the creation and/or update to internal and vendor provided design specifications, P&IDs, GA drawings, user requirements, functional specifications in accordance with industry standards and best practices. Drive standardization within the department and company.
- Write and review technical documentation such as protocols and reports for FATs, SATs, and commissioning.
- 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 for manufacturing deviations and anomalies related to failure of facility and utility systems.
- Perform utility monitoring, utility capability, statistical analysis and quality engineering activities.
- Provide support for technology transfer of new processes to the manufacturing area, including review for facility fit and identification of any required utility equipment modifications that would be needed to support the new process.
- Manage procurement activities for new utility equipment or modifications to existing utility systems.
- Provide afterhours technical and troubleshooting support as needed.
- Other duties as assigned.
Utility Engineer II
- Bachelor’s degree in Engineering with minimum 2 years of related experience supporting manufacturing operations
Utility Engineer III
- Bachelor’s degree in Engineering with a minimum 5 years of related experience supporting manufacturing operations
Knowledge, Skills and Abilities
- Working knowledge of cGMP manufacturing and regulatory requirements for biologics and pharmaceuticals.
- Knowledge of quality systems including deviations, change controls and CAPAs.
- Ability to write technical reports and to develop project schedules.
- Capable of effectively negotiating contracts, bids, and change orders with vendors or contractors for support or procurement of equipment or systems
- Capable of performing risk assessments.
- Willingness to work with a “hands-on" approach in project construction, testing, and support.
- Must have effective interpersonal and oral/written communication skills.
- Excellent troubleshooting and 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.
- Experience as a Utility Engineer in biotech or the pharmaceutical industry
- In-depth understanding and knowledge of Clean Utility Systems including; purified water (RODI and WFI) generation and distribution, clean steam generation and distribution, HVAC for clean rooms, compressed air generation and distribution and process gas (carbon dioxide and oxygen) storage 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, uninterrupted power supply systems and diesel electric generators.
- 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, CFR’s, NEC and/or ASHRAE.
- Understanding of Emerson DeltaV Distributed Control Systems, Rockwell/Allen Bradley Control Systems, Siemens Apogee or Desigo Building Management Systems and/or Blue Mountain Regulatory Asset Manager.
- Equipment qualification experience in a cGMP environment (IQ, OQ, PQ)