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28 days old

Senior Validation Engineer

Kelly Services
Summit, NJ 07901
Kelly Services is seeking an **Validation Engineer-** for our well-known client in the **Pharmaceutical industry** in **Summit NJ.** **This is a 7-month contract to hire position.**



**Title: Validation Engineer**



**Location:** **Summit NJ**



**Duration: 7-months**





The CSV Engineer supports the successful implementation of manufacturing and laboratory equipment and computerized systems at multi-use sites through interaction with internal customers and external service providers. The incumbent in this role, contributes to the completion of milestones associated with equipment qualification and systems validation. With minimum supervision and given general instructions, this individual carries out routine tasks and functions, and uses basic analytical skills to recognize and solve common problems of limited scope. As a developing team player, the incumbent interacts with their immediate supervisor and personnel within their own work group to achieve team goals while building trust and collaborative relationships outside the immediate organization.





**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.

+ 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 Client 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.





**Education/Qualifications**




+ BS degree in Engineering / Computer Science or equivalent

+ Minimum 5 years of experience in FDA-regulated industry, with 5 years experience in CSV



**Knowledge, Skills & Abilities** :




+ 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.



**Why Kelly?**



As a Kelly employee, youll have access to premier perks, including:




+ Kelly-sponsored Affordable Care Act health care coverage available to eligible employees

+ Group insurance options

+ Service bonus plan

+ Holiday pay plan

+ Weekly electronic pay options

+ Online training campus that provides more than 3,000 free courses to help improve and develop skills

+ Outstanding online employee community Corporate discounts




+ Transportation Spending Accounts

+ Offered and coordinated by Leslie & Associates. These plans are not sponsored by Kelly Services.




**Why Kelly** **** **?**



As a worker today, its up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find whats next is what were all about. We know whats going on in the evolving world of workjust ask the nearly 500,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.




**About Kelly** ****



At **Kelly** , were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

\#KellyGTS
Posted: 2020-10-30 Expires: 2020-11-30

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Senior Validation Engineer

Kelly Services
Summit, NJ 07901

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