Job Title: Validation Engineer

Location: Summit, NJ

Hours/Schedule: M- F (Should be flexible on timings based on business needs)

Type: Contract

Responsibilities

• Maintains all qualified and validated equipment and systems in compliance with policies, guidelines and procedures.

• 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.

• 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, and 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 qualification and validation documentation with accuracy, completeness, and compliance to Company 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

• Strong working knowledge of MS Windows client and server technologies.

• Working knowledge of standard networking principles and technologies.

• Excellent understanding of cGXP requirements and good documentation practices relating to systems, equipment, and instrumentation within the pharmaceutical industry.

• Strong working knowledge of ISPE guidance and 21 CFR Part 11 compliance.

• Ability to work with the end user to identify and document User and Functional Requirements.

• Knowledge of pharmaceutical laboratory and manufacturing systems.

• Experience executing equipment 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.

  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.