Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek -- so they can do what they do best: improve the world around us. Information about Agilent is available at www.agilent.com.
The Facilities Engineer is recognized as a strong technical contributor within Workplace Services (WPS) supporting both GMP and Non-GMP utilities and equipment required for the Frederick and Boulder sites. This position will report to the Director of WPS (Work Place Services) & EHS for Colorado.
You will manage certain utilities at the site, including domestic water, HVAC, electricity, and other supporting equipment and infrastructure. You will handle all aspects of coordinating activities with other departments including Manufacturing, Maintenance, Engineering, Quality Assurance, Validation, Quality Control, etc. In addition, you may also collaborate with customer personnel, auditors, and regulatory authorities, as needed, to communicate system design, qualification, and status of WPS maintained systems. This role requires a significant amount of internal engagement with system users and EHS function through strong interpersonal skills, influence management and change management. You will implement and ensure the execution of key initiatives against timeline and deliverables, including identifying bottlenecks, resolving issues, and driving towards effective and standardized completion.
The Facility Engineer is an individual contributor within the WPS/EHS team. A strong predictor of success for this role is being able to be flexible and multi-task while working on several project timelines independent of each other. Must influence others through your knowledge of regulations that support the facility, process, and safety needs. Strong project management skills as demonstrated through collaboration with multiple departments and external partners/vendors are critical for you to maintain timelines and to keep the facility activities on track.
Strong technical engineering skills. Able to work within a multi-functional team, and excellent interpersonal and team-building skills. You will handle maintaining reliability with WPS maintained utilities to establish a culture of continuous improvement and strengthen troubleshooting programs, identify root cause, and make appropriate corrective actions at our Colorado manufacturing sites.
Professional Skills, Qualifications and Knowledge needed to be successful in this role:
- Strong business acumen
- Support all activities associated with the site's utilities, including but not limited to, operation, qualification, preventative maintenance, change control, shut-down activities, risk assessments, leading investigations, troubleshooting, root cause analysis and CAPA implementation.
- Ensure that all planned and unplanned work is prioritized and managed closely to minimize equipment downtime and disruptions to the manufacturing schedule. Clear, concise, and timely communications regarding these activities to all relevant partners (i.e.-manufacturing, quality assurance, engineering/process maintenance, leadership, etc.).
- Maintenance of quality systems and cGMP compliance
- GMP Documentation: Responsible for new and replacement equipment install and operational validations. Support validation of the facility with proper GMP documentation. Additionally, support the facility design and changes with CAPA, Change Controls, Deviations, etc.
- Developing Compliant Systems: Develop and maintain standard operating procedures and other procedures for systems to support the facility. Design, support. maintain and comply with engineering standards, P&IDs, project controls that allow for WPS to operate successfully.
- Ability to understand regulatory requirements such as ICH Q7, 21CFR Part 210 and 211, 21CFR Part 600, and EMA guidelines as they relate to utilities and pharmaceutical manufacturing.
- Supports equipment commissioning, qualification and validation activities related to systems owned by WPS.
- Experience with BAS
- Experience with CAD and MS Office
- Write, review and/or assist in the development of SOPs in a timely manner.
- Identification, recommendation, and implementation of replacement-in-kind, new or improved equipment and/or systems in support of existing utilities as well as new or existing manufacturing processes.
- Inspect and review projects to monitor compliance with building and safety codes, and site regulations.
- Ability to read and interpret P&IDs, equipment manuals and electrical/mechanical drawings.
- Work with other disciplines to ensure the necessary details related to the systems are fully coordinated, understood, and scheduled.
- Research equipment providers and make recommendations and selections based on project requirements and business needs.
- Drive continuous improvement to support customer and regulatory expectations. Support and participation in client and regulatory audits.
- Ability to build, lead and motivate teams of employees and strategic outsource vendors.
- Highly skilled at influencing major clients and partners through strong relationships, expertise, and data.
- Strong problem-solving and negotiation/influencing skills.
- Ability to produce and deliver executive-level presentations; strong executive presence; ability to read audiences and adapt communication style and delivery of information accordingly.
- Ability to quickly develop a thorough understanding of all areas of the organization and of the organization's key functional processes and resources.
- Ability to make, own, and communicate hard decisions.
- Able to operate and collaborate within a matrix organization.
- Good balance of strategic and tactical skills.
- Navigate ambiguity and deal with constant change and take measured risks.