Validation Support

Job Title: Validation support

Location: Summit, NJ

Type: Contract

Responsibilities

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.

Develops written procedures for calibration and preventive maintenance of equipment

Supports calibration, equipment qualification and validation activities.

Configures and documents the configuration of computerized systems

Develops validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports, Change Controls.

Manages projects of varying scope and complexity.

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

Supports internal customer groups in the procurement, operation, calibration, and preventive maintenance of equipment to meet business needs in accordance with required schedules or dates.

Completes all calibration, qualification and validation documentation with accuracy, completeness and compliance to Celgene standards.

Provides excellent customer service and support.

Regularly reviews, prioritizes and promptly responds to customer equipment qualification and support requests.

Provides technical support and guidance on calibration and equipment qualification issues. Interfaces with customers to ensure all expectations are being met.

Maintains a positive relationship with all team members and site customers while promoting a positive team environment.

Requirements

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

Education & Experience:

BS degree in Engineering / Computer Science or equivalent

Benefits

System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.