Brooksource · 7 hours ago
Utilities Engineer
Concord, NC
Contract
Onsite
Senior Level
$65/hr - $75/hr
7+ years expBrooksource is seeking a Clean Utilities Engineer who will provide key support for GMP Utilities systems. The role involves both project phase responsibilities for a new manufacturing line and operational support for existing lines, ensuring compliance and reliability of utilities systems.
EmploymentHuman ResourcesInformation Technology
Hiring Manager
Caleb Reitz
Responsibilities
Act as a core member of the cross-functional project team responsible for the design, construction, commissioning, qualification, start-up, and operational readiness of all GMP Utilities
Provide technical input and oversight to ensure utilities systems meet GMP, regulatory, and site requirements
Support transition from project execution to steady-state operations
Ensure effective, reliable, and cost-efficient operation of site GMP Utilities and associated ancillary systems
Maintain utilities systems in a compliant, in-control, and fit-for-use state to meet all site operational needs
Monitor utilities performance and maintain KPIs to drive operational excellence
Lead investigations of out-of-specification (OOS) or adverse trends, performing root cause analysis (RCA) and implementing effective CAPAs
Develop and maintain written operating and maintenance instructions to ensure systems operate within validated and controlled parameters
Implement efficient maintenance and reliability strategies in collaboration with maintenance and operations teams
Lead troubleshooting of equipment failures and guide operations personnel in resolving process and utilities-related issues
Provide technical support to maintenance and operations as required
Communicate effectively with internal customers and provide timely consultation and notifications related to utilities issues
Support internal and external inspections, audits, and investigations, including Quality and HSE engagements
Maintain strong communication and collaboration with site customer groups
Qualification
Required
Bachelor of Science (B.S.) in Chemical Engineering or Mechanical Engineering
Minimum of 7 years of engineering experience in the pharmaceutical industry
Strong knowledge of GMP utilities systems and regulatory expectations
Demonstrated expertise in RCA, CAPA development, and cross-functional collaboration
Preferred
Proficiency with TrackWise, Veeva Vault, and CAPA management systems
Experience with maintenance and computerized maintenance management systems (CMMS)
Company
Brooksource
Brooksource is a single source for project and supplemental support through contract employment, contract-to-hire labor employment.
1001-5000 employees
H1B Sponsorship
Brooksource has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2020 (10)
Funding
Current Stage
Late StageLeadership Team
Ashley Cigolotti
Director, Global Partnerships
Matt Ayala
National Account Executive (Global Partnerships)
Recent News
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