Validation Engineer

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.

• Analytical Equipment Ownership

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

• Participate on Risk Assessments

• Review/Approve Commissioning Qualification Validation Documents

• 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: x 324 Cell: Fax: Email: