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Validation Engineer

Net2Source Inc.

Portsmouth (NH)

On-site

USD 80,000 - 100,000

Full time

7 days ago
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Job summary

An established industry player is seeking a passionate Analytical Validation Specialist IV to lead validation activities for analytical systems. In this role, you will collaborate with multiple departments to ensure compliance and quality performance. Your expertise in quality control and project management will be crucial in driving improvements and supporting operational excellence. Join a dynamic team where your contributions will make a significant impact in the pharmaceutical manufacturing sector. If you are ready to take on new challenges and drive talent acquisition strategies, this opportunity is perfect for you.

Qualifications

  • Advanced technical knowledge of Quality control and manufacturing operations.
  • Working knowledge of Quality Systems and practical applications.

Responsibilities

  • Lead validation activities for analytical systems and equipment.
  • Drive validation plans and execution of equipment changes.

Skills

Quality Control
Analytical Equipment Troubleshooting
Project Management
MS Project
Communication Skills

Education

Bachelor's Degree in Engineering or related field

Tools

TrackWise
MS Office Suite

Job description

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This range is provided by Net2Source Inc.. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$70.00/hr - $79.00/hr

Direct message the job poster from Net2Source Inc.

Passionate Recruitment Lead | Driving Talent Acquisition Strategies | Building High-Performing Teams & Cultures

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

Description:

Job Title: Analytical Validation specialist IV

Location: Portsmouth, NH 03801

Duration: 12+ Months (Extendable)

Pay Rate: $70.00 – 79.00/hr on W2

Description:

Analytical Validation specialist IV will lead validation activities including, but not limited to, software updates, new system introduction, and decommissioning of analytical systems. This person will work closely with other functional groups like Manufacturing, Operations Technology, Computer System Validation, Engineering, and Quality Assurance to support updates to help the site remain in compliance and contribute to quality, on-time delivery and right first time performance.

Responsibilities:

• Provide Subject Matter Expert support to Quality Control, Manufacturing and other departments for the design, operation and troubleshooting of analytical equipment.

• Drive/own the validation plans and execution of analytical equipment changes and process improvements.

• Execution of Installation Qualifications/Operational Qualifications and drafting Performance Qualifications as required

• Own all forms of TW records including CC/CAPA/Deviations to support project completion.

• Generating User Requirements Specification Documentation, complete Electronic Records/Electronic Signatures, Data Integrity Risk Assessments and Audit Trail Risk Assessments.

• Review analytical equipment, manuals, and devise validation plans

• Procurement of Analytical Equipment which includes ensuring system meets specifications, quotes, budgets and installations.

• Identify Quality Issues, involve stakeholders, drive to completion/resolution

• Participate on Risk Assessments

• Perform other duties as assigned.

Skills:

• Advanced technical knowledge of Quality control and manufacturing operations.

• Working knowledge and experience with Quality Systems including deviations, change controls, CAPAs, OTNs, deviations; both the system (TrackWise) and the practical applications in operations

• Knowledgeable in process, equipment, cleaning, and computer system validations to the extent of being able to effectively review and approve protocols and reports and support implementation of new equipment.

• Demonstrated ability to manage medium to large sized projects within required timeframes.

• Demonstrate ability for effective Planning, Organizing and Controlling competency

• Demonstrate sound decision making.

• Ability to work inter-departmentally and with customers.

• Demonstrates role model behaviors for GMP and Safety behaviors

• Strong written and verbal communication skills

• Ability to work in MS Project, Word, Excel, PowerPoint

Regards,

Prateek Pampattiwar

Recruitment Specialist

Net2Source Inc.

Global HQ Address –270 Davidson Ave, Suite 704, Somerset, NJ 08873, USA

Office: (201) 340-8700 x 324 | Cell: (551) 220 3007| Fax: (201) 221-8131| Email: Pampattiwar.Prateek@net2source.com

Seniority level
  • Seniority level
    Mid-Senior level
Employment type
  • Employment type
    Contract
Job function
  • Job function
    Engineering and Manufacturing
  • Industries
    Pharmaceutical Manufacturing

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