Validation - Validation Specialist

Senior Validation Specialist

Warren, NJ--Onsite

Work Schedule:

Mon - Fri, Business Hours The Senior Validation Specialist, Computerized Systems, is responsible for performing initial and routine validation activities for GxP computerized systems. Primary responsibilities include: qualification of laboratory instruments, setup of computers and instruments, troubleshooting of system related issues, and technical writing and execution. Executes validation projects, system qualification, and implements industry best practices for the design and delivery of GxP computerized systems.

1.

Required Competencies:

Knowledge, Skills, and Abilities:

• Working understanding of validation concepts and requirements.
• Intermediate written and verbal communication skills.
• Knowledge of cGMP.
• Critical reasoning and decision making skills.
• Knowledge of validation industry and regulatory requirements.
• Ability to work independently and participate in a team.
• Work and time management skills.
• Working proficiency in Microsoft Word, Outlook, Excel, PowerPoint, and Project.

2.

Duties and Responsibilities:

• Performs validation document generation, program management, and protocol execution activities.
• Interface with Engineering, and end user groups to support development of life cycle documents and system requirements.
• Design the validation approach with technical oversight, provide the scientific rationale and acceptance criteria, and generate validation protocols.
• Execute validation studies, perform data analysis, and write protocol summaries, reports, and technical reports.
• Execute qualification activities with oversight.
• Participate in department and site project teams.
• Perform qualification activities according to site objectives and timelines.
• Edit department SOPs and generate basic revisions as required.
• Execute CAPA plans, risk assessments, investigations, and root cause analysis.
• Working understanding of site quality GxP systems supporting document management, change controls, deviations, CAPAs.
• Defend validation protocols in internal and external audits as a subject matter expert with limited supervision.
• Interact and collaborate with departments (on and offsite) as well as vendors, consultants and other external service providers.
• Performs general administrative and organizational activities.
• Management of time and work deliverables, regular interface and reporting to management.
• Complete regulatory, site, and department training requirements on a timely basis.
• Perform other tasks as assigned.

3.

Education and Experience:

• Bachelor's degree preferred, preferably in Science or Engineering.
• 8 years relevant work experience required.
• An equivalent combination of education, experience and training may substitute.

4.

Working Conditions:

The incumbent may be required to gown and operate in classified manufacturing environments.