Senior Validation Specialist (Utilities and Facilities) LL02-250903
$90,000–$120,000 year
Remote · United States or Puerto Rico
United States or Puerto RicoRemoteFull Time$90,000–$120,000 yearSenior LevelBachelors DegreeUnknown
Type
Full Time
Level
Senior Level
Education
Bachelors Degree
Company size
Unknown
Job Summary
Seeking a Senior Validation Specialist for Utilities and Facilities with a Bachelor's degree in Engineering and 8 years of experience in commissioning and validation within the pharmaceutical sector. Responsibilities include ensuring utility systems compliance, executing commissioning activities, and providing technical documentation.
Required Qualifications
- Bachelor’s degree in Engineering (Mechanical, Electrical, Chemical, or Civil), or a related technical field
- minimum 8 years of experience in commissioning, qualification, and validation of utilities and facilities in a pharmaceutical, biotech, or regulated manufacturing environment
- Hands-on experience with systems such as HVAC, purified water, clean steam, compressed air, and cleanrooms
- Strong technical writing skills for protocol and report development
- Proficient in using calibration and validation tools (e.g., thermal mappers, particle counters, flow meters)
- Excellent organizational and project management skills
- Effective communication and troubleshooting abilities
- In-depth knowledge of GMP, USP, ISPE, and ISO standards related to utilities and facilities
- Familiarity with validation guidelines (e.g., ICH Q9, ASTM E2500)
- Understanding of cleanroom classification and monitoring (ISO 14644-1, EU GMP Annex 1)
Desired Qualifications
- Certification in validation or engineering disciplines (e.g., ISPE, ASHRAE)
- Experience with utilities automation systems (e.g., SCADA, PLCs)
- Knowledge of energy efficiency principles and sustainability practices for facility systems
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