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22 часа назад

Senior/Principal Clean Utilities Specialist - CVRM (Holly Springs)

63 500 - 151 200$
Формат работы
hybrid
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Senior/Principal Clean Utilities Specialist - CVRM (Holly Springs) (cGMP clean utilities): Operating, maintaining, and commissioning clean utility and plant utility systems for a greenfield biomanufacturing facility with an accent on water-for-injection, clean steam, HVAC, electrical, and control systems. Focus on establishing maintenance programs, supporting startup and qualification, troubleshooting PLC/automation, and maintaining audit-ready GMP operations.

Location: Holly Springs, North Carolina, United States; initially a mix of remote and onsite work, transitioning to full-time onsite work at the Holly Springs site. Up to 30% travel is expected during the project phase. The role includes a defined shift with flexible hours, overtime, and on-call coverage.

Salary: $63,500–$151,200 per year, depending on experience, level, qualifications, geographic location, and other permitted factors. A discretionary annual bonus may be available.

Company

hirify.global, a member of the Roche group, develops medicines and operates a greenfield biomanufacturing facility supporting its Cardiovascular, Renal, and Metabolic mission.

What you will do

  • Operate, maintain, repair, and troubleshoot clean utility and plant utility systems supporting 24/7 manufacturing, laboratory, and warehouse operations.
  • Support design review, installation, commissioning, qualification, FATs, SATs, and system turnover for clean utility and process equipment.
  • Establish the site maintenance program, including procedures, training programs, spare-parts strategy, SAP master data, and maintenance plans.
  • Perform preventive maintenance, repairs, asset replacements, safe shutdowns and startups, and field execution on GMP assets.
  • Support PLC and automation troubleshooting, facility alarms, change management, deviations, investigations, root-cause analysis, and technical reporting.
  • Collaborate with Engineering, MSAT, Quality, QC, Supply Chain, Production, and external service providers while maintaining audit readiness.

Requirements

  • Senior level: high school diploma or equivalent with 10+ years of related industrial or manufacturing experience, or a preferred associate degree, A.A.S., or trade school certificate with 8+ years of experience.
  • Principal level: high school diploma or equivalent with 14+ years of related industrial or manufacturing experience, or a preferred associate degree, A.A.S., or trade school certificate with 12+ years of experience.
  • Extensive experience with utility, HVAC, electrical, maintenance operations, engineering support, equipment installation or service, or instrument calibration/programming in a regulated environment.
  • Familiarity with cGMP, health authority regulations, quality systems, classified environments, aseptic processing principles, Building Management Systems, CMMS, and predictive maintenance technologies.
  • Ability to interpret mechanical drawings, electrical schematics, hydraulic and pneumatic diagrams, and P&IDs; proficiency with SOPs, documentation practices, SAP S/4HANA, and standard computer tools.
  • Ability to work onsite in Holly Springs, including clean-room gowning, exposure to hazardous materials and equipment, lifting up to 50 lbs, climbing stairs or ladders, and extended periods of standing.

Culture & Benefits

  • Work in a startup environment building a state-of-the-art greenfield biomanufacturing facility planned for operational launch in 2028.
  • Safety-first and cGMP-focused work environment with formal and informal training, coaching, and mentorship responsibilities.
  • Opportunity to contribute to a critical manufacturing infrastructure supporting medicines for serious and life-threatening diseases.
  • Equal opportunity employment with accommodations available for applicants with disabilities.

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