Net2Source Inc. is an award-winning total workforce solutions company recognized by Staffing Industry Analysts for our accelerated growth of 300% in the last 3 years with over 5500+ employees globally, with over 30+ locations in the US and global operations in 32 countries.
We believe in providing staffing solutions to address the current talent gap - Right Talent - Right Time - Right Place - Right Price and acting as a Career Coach to our consultants.
Company:
One of Our Clients
Job Description:
Position:
Validation Engineer
Location:
Summit, NJ % Remote & 50% Onsite)
Duration: 12+ Months (Extendable)
No of Positions:
5
Pay Rate:
$ /hr on W2
Position Overview:
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.
Essential Functions:
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 equipment qualification and systems 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 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.
Required Competencies-Knowledge, Skills, and Abilities:
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.
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 experience (degree not required)
- Minimum 5 years of experience in FDA-regulated industry, with 5 years experience in CSV
Working Conditions:
Environmental 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.
Equal Employment Opportunity Statement:
Net2Source is an Equal Opportunity Employer. We believe that no one should be discriminated against because of their differences, such as age, disability, ethnicity, gender, gender identity and expression, religion or sexual orientation.
Our rich diversity makes us more innovative, more competitive, and more creative, which helps us better serve our clients and our communities.
All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law.
Awards and Accolades:
America's Most Honored Businesses (Top 10%)
Awarded by USPAAC for Fastest Growing Business in the US
12th Fastest Growing Staffing Company in USA by Staffing industry Analysts in the US (2020, 2019, 2020)
Fastest 50 by NJ Biz (2020, 2019, 2020)
INC 5000 Fastest growing for 8 consecutive years in a row (only 1.26% companies make it to this list)
Top 100 by Dallas Business Journal (2020 and 2019)
Proven Supplier of the Year by Workforce Logiq (2020 and 2019)
2019 Spirit of Alliance Award by Agile1
2018 Best of the Best Platinum Award by Agile1
2018 TechServe Alliance Excellence Awards Winner
2017 Best of the Best Gold Award by Agile1(Act1 Group)
Regards,
Kenneth Solomon
Delivery Lead (Pharma and LifeSciences)
Net2Source Inc.
Global HQ Address -270 Davidson Ave, Suite 704, Somerset, NJ 08873, USA
Office:
x 606 | Cell: | Fax: | Email:
#LSC1
Net2Source (N2S)