Senior Validation Engineer

Position: Analytical Validation Specialist IV, Req#: LZAJP00005451

Location: Portsmouth, NH (100% Onsite only)

Duration: 12+ Months Contract

Job Description:

An 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.

Key Accountabilities :

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 the system meets specifications, quotes, budgets and installations.

Analytical Equipment Ownership

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

Participate in Risk Assessments

Review/Approve Commissioning Qualification Validation Documents

Perform other duties as assigned.

Education and Experience:

Bachelor of Science preferred

Advanced - 5-10 years of experience

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 interdepartmentally 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