Social network you want to login/join with:
The Site Utility Engineering Subject Matter Experts (SMEs) will act as Utility System Owners for Black and Clean Utilities. They will be responsible for providing engineering oversight, technical support, and continuous improvement for assigned utility infrastructure, systems, and equipment across the site.
Key Responsibilities:
* Ensure all utility systems are compliant with applicable regulatory standards, including cGMP, cGDP, EHS, global engineering directives, and local regulations.
* Lead the development of User Requirements Specifications (URS) for new equipment and modifications to existing systems, collaborating closely with internal stakeholders.
* Maintain and update asset records, calibration data, preventive/predictive maintenance (PM/PdM) schedules, job plans, and spare parts inventory within the CMMS.
* Conduct root cause analyses (e.g., Cause Mapping) on chronic, critical, or high-impact equipment failures and implement corrective actions.
* Minimize unscheduled downtime by enhancing maintenance strategies and responding swiftly to equipment failures.
* Review vendor and contractor maintenance reports, initiate CMMS actions (e.g., corrective maintenance, PM, PdM) to address any deficiencies.
* Act as system and area owner by conducting risk assessments, leading RCA investigations, and driving CAPA implementation to prevent recurrence of issues.
* Own and manage change controls related to assigned utility systems.
* Represent utility systems as the Subject Matter Expert (SME) during internal and external audits.
* Establish and track key performance indicators (KPIs) for system performance, including cost, efficiency, and uptime.
* Develop and manage annual operating budgets and identify cost-effective system improvements or upgrades.
* Define scopes and provide project management support for capital projects and system modifications.
* Champion a culture of continuous improvement and operational excellence.
* Proven team leadership and collaboration skills within a cross-functional, high-performance environment.
* Ability to deliver engineering solutions aligned with business goals and cost efficiency.
* In-depth knowledge of utility system design, operation, and maintenance in GMP-regulated facilities.
* Strong understanding of regulatory requirements, including EHS and quality compliance within pharmaceutical/biopharmaceutical environments.
* Prior experience representing utility systems to regulatory authorities is essential.
Qualifications & Experience:
* Minimum of a Level 8 Bachelor of Engineering (BEng) degree in a relevant engineering discipline.
* At least 8 years of experience in pharmaceutical manufacturing, with a focus on utilities or maintenance engineering.
* Strong problem-solving skills, with the ability to take initiative and lead technical investigations and system improvements.
* Familiarity with CMMS systems and a structured approach to maintenance planning and execution.
#J-18808-Ljbffr