Commissioning/Qualification

Responsibilities:

• Maintains all qualified and validated equipment and systems in compliance with policies, guidelines and procedures.
• Support Lifecycle Document Management System.
• Develops protocols, and associated reports while adhering to a change management process.
• Supports the execution of equipment qualifications and validation protocols.
• Supervises vendors for qualification functions.
• Configures and documents the configuration of computerized systems.
• Develops validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports.
• Supports laboratory and manufacturing equipment implementation projects. including scheduling, procurement, site prep, installation, qualification, and turn over to business area.
• Independent ownership of all lifecycle deliverables in the Qualification of equipment and full CSV for single and multi-user Computerized Systems.
• Provides excellent customer service and support.
• Regularly reviews, prioritizes and promptly responds to customer equipment qualification and support requests.
• Maintains a positive relationship with all team members and site customers while promoting a positive team environment.

Requirements:

• BS degree in Engineering / Computer Science or equivalent with 2 years of experience OR.
• Associate degree with at least 4 years of relevant experience.
• Strong critical thinking skills.
• Ability to learn and function in a fast-paced environment.
• Experience executing qualification documents.
• Ability to interact effectively with laboratory, QA, and Facilities groups.
• Strong ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion. 
• Ability to effectively manage multiple tasks and activities simultaneously.
• Strong written and verbal communication skills along solid presentation skills. Proficient at writing well-formulated emails and reports. Ability to follow oral and written instructions, read and interpret engineering manuals/drawings relevant to the assigned task. Ability to effectively communicate with employees, contractors and vendors. Experience with technical writing and document development / generation.
• Strong computer skills in Microsoft Office Suite – Word, Excel, Visio and Outlook, and the ability to learn new software as required for equipment qualification.
• CSV experience, Draft Qualification/validation documents such as Val Plan, IQ/OQ/PQs, RTMs, Summary Reports, Deviations, Test Plans, worked with change management, cross functional team experience.

Competencies:

• Technical / Professional Knowledge.
• Problem Solving / Troubleshooting.
• Action Oriented.
• Attention to Detail.
• Multi-tasking.
• Building Relationships.