Commissioning/Qualification and Validation Specialist

Minimum 50% onsite required
work schedule- Normal Business hours

Must Haves:
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.
Manager is looking for intermediate level(4-7) years, do not submit candidates with 10+ years.
They should know 21CFR Part 11 Requirements, Data integrity, experience with drafting URS, writing test protocols, Validation Plan.
Knowledge of folder permissions.


Essential Functions:
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.

Required Competencies-Knowledge, Skills, and Abilities:
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.
Competencies:
Technical / Professional Knowledge
Problem Solving / Troubleshooting
Action Oriented
Attention to Detail
Multi-tasking
Building Relationships

Education & Experience:
BS degree in Engineering / Computer Science or equivalent with 2 years of experience OR
Associate degree with at least 4 years of relevant experience

Working Conditions:
Environment may include working in office or in a laboratory / manufacturing area.
Ability to work safely in an environment with hazardous, radioactive, and infectious materials and waste.
Ability to work safely when working alone, or working with others.

No Travel required.

The starting hourly compensation for this assignment is within the range of $50 to $51/hr. Please note that the final individual compensation and any applicable benefits will be determined by your employer of record (and not Client). Factors influencing this decision may include the characteristics of the assignment, such as demonstrated experience, required skill, and the geographic location of the job. Compensation details are subject to change.
Additional Job Requirements: