Validation Analyst

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Job Description

Purpose :

Provides essential business and system support for software systems and laboratory instrumentation. Collaborates with various departments to initiate and complete performance qualification (PQ) validation facilitating the validation process and implementing system upgrades.

Essential Functions :

• Participate as a validation representative at project team meetings completing assigned action items. Provide direction for future software releases and review change requests. Communicate proactively with all project team members offering regular feedback to management concerning timeline budget or resource constraints.
• Guide future software releases and review change requests.
• Communicate with project team members providing feedback on timelines budgets and resources.
• Support new releases and modifications throughout the software development life cycle by preparing validation plans test cases and documentation.
• Review PQ and change control documentation with leadership per SOP.
• Ensure test scripts meet functional requirements and business expectations.
• Complete test scripts to verify system performance and reliability.
• Manage data within the testing environment to accurately test software functionality.
• Address PQ-related issues from client or internal audits with leadership.
• Manage assignments to meet deadlines and produce high-quality work while staying updated on relevant regulations and SOPs.
• Identify user requirements and assist in system design and documentation.

Job Complexity :

Handles problems of moderate scope requiring analysis of various factors.

Job Knowledge :

Develops professional expertise by applying company policies and procedures to resolve issues.

Supervision Received :

Receives general instructions for routine work and detailed instructions for new projects. Exercises judgment within defined procedures to determine appropriate actions.

Business Relationships :

Primarily interacts internally with occasional external customer / vendor contact on routine matters. Builds productive working relationships.

Qualifications :

Education and Experience :

Knowledge Skills and Abilities :

Management Role :

No management responsibilities.

Working Conditions and Environment :

Office environment with exposure to electrical office equipment.

Physical Requirements :

Required Experience :

IC

Key Skills

Python,SOC,Debugging,C / C++,FDA Regulations,Minitab,Technical Writing,GAMP,OS Kernels,Perl,cGMP,Manufacturing

Employment Type : Full-Time

Experience : years

Vacancy : 1