Validation Specialist II, Equipment
United Therapeutics Corporation
6 months ago
On-site
Silver Spring, MD
Operations
Responsibilities:
- Work under general supervision to apply and develop validation expertise to resolve moderately complex equipment validation issues and consult higher-level staff for more complex issues
- Develop and execute protocols; summarize reports supporting validation of equipment, computer systems, and processes
- Collect, compile, and analyze validation data and information to confirm equipment validated state for GMP use
- Participate on project teams requiring validation support
- Exercise judgment within defined procedures to determine appropriate action or recommend alternative solutions
- Communicate validation status effectively (written and oral) cross-functionally
- Contribute to Validation organization goals; may lead small initiatives
- Support validation change control activities and prepare/assess validation-related change control requests
- Revise validation SOPs and lifecycle validation documentation
- Perform equipment and other validation-related requalifications and periodic reviews
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; able to prioritize
- Effective cross-functional communication with colleagues and management
- Adaptable to change; influence and may guide junior/support team members
- Ability to work with minimal supervision
- Validation datalogger software knowledge (Amphenol/Ellab) for temperature/humidity mapping
- TrackWise, MasterControl, Blue Mountain RAM (or comparable) and/or electronic document management systems
- Regulatory requirements knowledge (US FDA and EU); communicate with regulators 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 (e.g., HPLC, UPLC, spectrophotometers, LAL readers, TOC analyzers)
- Ability to qualify processing equipment (e.g., autoclaves, isolators, bioreactors, tanks, depyrogenation tunnel, B/F/S, fluid bed granulator, tablet press/coaters, packaging lines, spray dryers, vision inspection systems)
- Ability to qualify utilities (e.g., purified water systems, compressed air, nitrogen, HVAC, WFI system)
Benefits:
- Eligible employees may participate in the company’s comprehensive benefits suite (medical/dental/vision/prescription, wellness resources, 401k and ESPP, paid time off and paid parental leave, disability benefits).
Job Location:
- On-site at Silver Spring, Maryland 100% of the time; ~10% travel expected.
- Work under general supervision to apply and develop validation expertise to resolve moderately complex equipment validation issues and consult higher-level staff for more complex issues
- Develop and execute protocols; summarize reports supporting validation of equipment, computer systems, and processes
- Collect, compile, and analyze validation data and information to confirm equipment validated state for GMP use
- Participate on project teams requiring validation support
- Exercise judgment within defined procedures to determine appropriate action or recommend alternative solutions
- Communicate validation status effectively (written and oral) cross-functionally
- Contribute to Validation organization goals; may lead small initiatives
- Support validation change control activities and prepare/assess validation-related change control requests
- Revise validation SOPs and lifecycle validation documentation
- Perform equipment and other validation-related requalifications and periodic reviews
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; able to prioritize
- Effective cross-functional communication with colleagues and management
- Adaptable to change; influence and may guide junior/support team members
- Ability to work with minimal supervision
- Validation datalogger software knowledge (Amphenol/Ellab) for temperature/humidity mapping
- TrackWise, MasterControl, Blue Mountain RAM (or comparable) and/or electronic document management systems
- Regulatory requirements knowledge (US FDA and EU); communicate with regulators 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 (e.g., HPLC, UPLC, spectrophotometers, LAL readers, TOC analyzers)
- Ability to qualify processing equipment (e.g., autoclaves, isolators, bioreactors, tanks, depyrogenation tunnel, B/F/S, fluid bed granulator, tablet press/coaters, packaging lines, spray dryers, vision inspection systems)
- Ability to qualify utilities (e.g., purified water systems, compressed air, nitrogen, HVAC, WFI system)
Benefits:
- Eligible employees may participate in the company’s comprehensive benefits suite (medical/dental/vision/prescription, wellness resources, 401k and ESPP, paid time off and paid parental leave, disability benefits).
Job Location:
- On-site at Silver Spring, Maryland 100% of the time; ~10% travel expected.