Senior Validation Engineer

Net2Source Inc.; Portsmouth (NH); On-site; USD 80,000 - 100,000; Full time

Job summary

An established industry player is seeking an Analytical Validation Specialist IV to lead validation activities and ensure compliance within their operations. This role involves collaborating with various departments to drive quality and performance improvements. Ideal candidates will have strong expertise in quality control processes, project management skills, and the ability to work effectively across teams. This opportunity offers a chance to contribute to impactful projects in a dynamic environment, making a significant difference in the quality of products delivered to clients.

Qualifications

• Lead validation activities for analytical systems and software updates.
• Support compliance and quality assurance across departments.

Responsibilities

• Provide SME support for analytical equipment and processes.
• Drive validation plans and execute analytical equipment changes.

Skills

Quality Control Knowledge

Project Management

Analytical Equipment Validation

GMP Compliance

Communication Skills

MS Project, Word, Excel, PowerPoint

Education

Bachelor's Degree in Engineering or Science

Tools

TrackWise

Job description

19 hours ago Be among the first 25 applicants

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.

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:

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

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,

Kajal Singh

Senior IT Recruiter (Pharma and Life Sciences)

Net2Source Inc.

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

Office: [phone] x 980 | Cell: [phone] | Fax: [phone]| Email: [e-mail]

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Engineering, Manufacturing, and Science

• Industries

  Biotechnology Research and Pharmaceutical Manufacturing

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