Job description
Job Duties: Project Stage Priority: Facility buildout complete
- Project
- On-site supervisor for completion of facility: cleanrooms/labs, office renovation, hot cells
- Support the installation/qualification of mechanical/HVAC, electrical, plumbing, cleanrooms, hot cells, fume hoods/isolators, control systems, BMS, fire safety, etc.
- Heavy emphasis on HVAC/cleanrooms/BMS
- Liaison with service providers
- Primary point of contact; supervise on-site work
- Obtain competitive quotes, select vendors, negotiate pricing, approve POs/vendor bills, cultivate relationships
- Manage contracts (e.g., pest control, fire monitoring/suppression, landscaping/snow, equipment PM/repair, custodial services)
- Assist with
- Safety programs: radiation, laboratory, occupational
- Facility licensing/compliance: RAM, effluents/emissions, sewer water/storm water, building codes (fire/electrical)
- Cleanrooms: Participate in cleaning, IQ/OQ/PQ
- Establish a system for scheduling/recording: warranties, inspections, PMs, repairs
Production Stage Priority: Facility ready to produce GMP doses
- Continue tasks above, as needed
- On-call to react to alarms/emergencies/urgent facilities problems that might cause production delays
- Production area: Ensure safety and readiness
- Inspections/PM/repairs of facilities-related equipment: In-house or supervise contractors (e.g., emergency showers/eyewash, fire sprinklers/extinguishers, emergency alarms/systems, backup power transfer)
- Facilities equipment: Manage warranties, service contracts; schedule PMs, requalification
- Documents for facility: Draft/review SOPs, IQ/OQ/PQ, other protocols/reports
- Maintain a stock of spare parts/other supplies
- Assist with budget forecasting of CapEx/OpEx
- Waste management: RAM, chemical, garbage, recycling
- Assist with investigations for Quality Unit (deviations/OOS/recalls/FMEAs)
- Facility renovations/expansions: planning, bidding, selection/contracting, design, project management
All Stages
- Frequent facility inspections inside/outside[HE(C5]
- Expert on the facility for inspectors/management/staff
- Review/approve documents: quotes/contracts, PMs, final reports, invoices
- Manage badge access system
- Attributes
o Character to exemplify: integrity, team spirit, service attitude, initiative, problem solving, attention to detail
- Embody a culture of safety, quality, continuous improvement, customer service
- Press toward ambitious goals/timelines; motivate colleagues
- Comply with SOPs, policies, regulations, laws
- Represent employer well at all times
- Location: On-site 100%; Travel <10%
- Other tasks/responsibilities as needed
Our Full-Time Benefits
- Competitive compensation
- Health, Dental, and Vision insurance - with generous employer contributions
- 401(k) with employer matching and contribution amounts
- Life insurance and Short- and Long-Term Disability insurance provided by the company
- Generous Paid Time Off and holiday schedules
- Numerous Training and Development opportunities
Ideal qualifications
Orano Med encourages applicants with military experience for this position. Required: Attributes
- Work with urgency to fix problems quickly for production at GMP standards
- Attention to detail; meticulous GDP documentation
- Physical: Safely lift 50 lbs.
Experience/Education
- Safety practices: construction site safety; occupational health/safety
- Facilities: 5+ yr. in any industry, incl. 2+ yr. pharmaceuticals
- Cleanrooms: 2+ yr.
- GMP: 1+ yr.
- Equipment: Installation, IQ/OQ/PQ, calibration, PM, systematic troubleshooting, basic repairs
Preferred: Attributes
- Problem solving: Identify, take initiative, overcome obstacles, solve the problem
- Adaptable: Work well leading a group or working independently
- Seize opportunities to work on a project or help with a task
- Verbal/written communication: concise, clear, efficient
- Service attitude toward colleagues
- Cross-functional teamwork/leadership
- Professionalism; organized work style/space
- Teachable: Open to constructive feedback.
Experience/Education
- Safety: laboratory, radiation
- Radioactivity: 2+ y
- Aseptic manufacturing: 2+ y
- Radiopharmaceuticals
- Software systems: QMS, BMS, EMS
- Technical writing (SOPs, protocols, reports)
- Commissioning new facilities
Education: Associate's or Bachelor's degree in a scientific/technical field Orano is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, age, disability, citizenship, veteran status, marital status, sexual orientation, gender identity, genetic predisposition or carrier status or any other characteristic protected by law.
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