UPS is seeking a Healthcare Facility Validation Engineer to provide guidance to UPS Supply Chain Solutions (SCS) management to maintain validation of environmentally-controlled Healthcare storage areas such as warehouses, cold chambers or computerized control and monitoring systems. The Healthcare Facility Validation Engineer assesses facilities, chambers or systems being evaluated for use in healthcare storage applications, identifies validation requirements and elevates validation issues appropriately. He/She also provides training and subject matter expertise to other functions as needed. This position drafts validation documents, such as validation master plans and qualification tests, and coordinates their review and approval. He/She performs or facilitates required validation testing, works to resolve any issues found and creates summary reports of qualification tests. He/She also determines applicable regulations and requirements for storing clients' healthcare products, and supports client/regulatory audits and inspections. This position is part of the UPS SCS Global Healthcare Facility Validation team and reports to the Healthcare Facility Validation Manager.

RESPONSIBILITIES AND DUTIES

• Remains current on applicable global regulatory requirements, accepted guidance (ISPE) and industry best practices (e.g. Pharmaceutical, Medical Devices, etc.) related to validation of environmentally-controlled storage and monitoring systems
• Serves as subject matter expert to other functions regarding requirements and best practices for validation of storage areas and equipment or systems involved, and provides general validation training as needed to other groups
• Identifies and assesses environmentally-controlled Healthcare storage areas, such as warehouses, chambers (coolers, freezers, vaults, etc.) or computerized control and monitoring systems, that require validation to be compliant with current Good Manufacturing Practices (cGMP) regulations
• Develops validation plans, such as Validation Master Plans (VMP), for environmentally-controlled Healthcare storage areas or computerized control and monitoring systems  
• Reviews technical documents and drawings (HVAC, BAS, controls, monitoring, etc.) provided by UPS Plant Engineering or design/installation vendors that describe systems to be designed, installed and requiring qualification testing (IQ, OQ, PQ)
• Writes and executes tests as stated in validation protocols, generates summary reports, and facilitates corrective actions for deviations found during testing
• Provides updates to Facility Validation management, either verbally or through written reports or communications, on the status of projects or ongoing validation activities related to facilities, chambers or systems
• Provides updates to new client Implementation Project Managers, either verbally on project update calls or through written reports or communications, on the status of validation activities and timelines associated with new client implementations or new construction projects (e.g. new/renovated warehouses, chambers or computerized control & monitoring systems)
• Interfaces with internal groups and attends project meetings to support the coordination of planned validation activities
• Communicates with Business Development and Solutions to support consultation on potential business opportunities
• Assists with reviews and revisions of some corporate standard operating procedures (SOPs) and work instructions (WIs) to ensure proper procedures are followed by Plant Engineering, Quality Assurance and Operations Groups
• Reviews and suggests revisions to change control procedures, training, and audits to ensure the maintenance of validation
• Identifies client product types and requested service requirements (e.g., storage, etc.) to determine applicable regulations
• Assists in establishing and completing risk assessment procedures and processes to support risk minimization

KNOWLEDGE AND SKILLS

• Bachelor’s Degree (or internationally comparable degree) in Engineering - Preferred
• Validation experience and HVAC and controls experience - Preferred
• Healthcare Industry experience (Pharmaceutical/Medical Device Warehousing & Distribution or Manufacturing) - Preferred
• Relevant QA/RA experience - Preferred
• CQE certification - Preferred
• Computer Aided Drafting (CAD) experience - Preferred

UPS is an equal opportunity employer. UPS does not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity or any other characteristic protected by law

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