Validation Specialist II, Equipment
United Therapeutics Corporation
1 month ago
On-site
Silver Spring, MD
Operations
Responsibilities:
- Work under general supervision to apply and grow validation expertise to resolve moderately complex issues
- Develop and execute protocols and summarize validation reports for equipment, computer systems, and processes
- Collect, compile, and analyze validation data to confirm the validated state of equipment for GMP use
- Participate on project teams to represent Validation internally
- Exercise judgment to determine appropriate action or recommend alternative solutions
- Communicate validation status effectively in writing and orally cross-functionally
- Contribute to department goals by leading small initiatives (limited resources and/or complexity)
- Support validation change control activities
- Revise validation SOPs and lifecycle validation documentation
- Perform equipment validation requalifications and periodic reviews (with general supervision)
Minimum Requirements:
- Bachelor’s degree in a scientific field
- 2+ years of relevant validation experience in a pharmaceutical/cGMP environment
- Working knowledge of Microsoft Office and email software
- Detail-oriented, self-motivated, organized; ability to prioritize
- Effective cross-functional communication with management and senior management
- Ability to adapt to change; ability to work with minimal supervision
- Ability to influence and may guide junior/support team members
- Working knowledge of validation datalogger software (Amphenol/Ellab) for temperature/humidity mapping
- Working knowledge of TrackWise, MasterControl, Blue Mountain RAM, and/or electronic document management systems
- Working knowledge of US FDA and EU regulatory requirements; communicate with regulatory agencies when applicable
- Ability to qualify Solid Dose, Dry Powder, API, Fill Finish, and/or Packaging processing equipment
Preferred Qualifications:
- Ability to qualify QC/analytical equipment (HPLC, UPLC, spectrophotometers, LAL readers, TOC analyzers)
- Ability to qualify processing equipment (autoclaves, isolators, bioreactors, tanks, depyrogenation tunnel, blow-fill-seal, fluid bed granulator, tablet press/coaters, packaging lines, spray dryers, vision inspection systems)
- Ability to quality utilities (purified water systems, compressed air, nitrogen, HVAC, WFI system)
Job Location:
- On-site at Silver Spring, Maryland 100% of the time; ~10% travel
- Work under general supervision to apply and grow validation expertise to resolve moderately complex issues
- Develop and execute protocols and summarize validation reports for equipment, computer systems, and processes
- Collect, compile, and analyze validation data to confirm the validated state of equipment for GMP use
- Participate on project teams to represent Validation internally
- Exercise judgment to determine appropriate action or recommend alternative solutions
- Communicate validation status effectively in writing and orally cross-functionally
- Contribute to department goals by leading small initiatives (limited resources and/or complexity)
- Support validation change control activities
- Revise validation SOPs and lifecycle validation documentation
- Perform equipment validation requalifications and periodic reviews (with general supervision)
Minimum Requirements:
- Bachelor’s degree in a scientific field
- 2+ years of relevant validation experience in a pharmaceutical/cGMP environment
- Working knowledge of Microsoft Office and email software
- Detail-oriented, self-motivated, organized; ability to prioritize
- Effective cross-functional communication with management and senior management
- Ability to adapt to change; ability to work with minimal supervision
- Ability to influence and may guide junior/support team members
- Working knowledge of validation datalogger software (Amphenol/Ellab) for temperature/humidity mapping
- Working knowledge of TrackWise, MasterControl, Blue Mountain RAM, and/or electronic document management systems
- Working knowledge of US FDA and EU regulatory requirements; communicate with regulatory agencies when applicable
- Ability to qualify Solid Dose, Dry Powder, API, Fill Finish, and/or Packaging processing equipment
Preferred Qualifications:
- Ability to qualify QC/analytical equipment (HPLC, UPLC, spectrophotometers, LAL readers, TOC analyzers)
- Ability to qualify processing equipment (autoclaves, isolators, bioreactors, tanks, depyrogenation tunnel, blow-fill-seal, fluid bed granulator, tablet press/coaters, packaging lines, spray dryers, vision inspection systems)
- Ability to quality utilities (purified water systems, compressed air, nitrogen, HVAC, WFI system)
Job Location:
- On-site at Silver Spring, Maryland 100% of the time; ~10% travel