Validation Coordinator (Utilities)

• Provide technical support to all departments in accordance with established Service Level Agreements and company standards.
• Responsible for ensuring that qualification of utilities is carried out in accordance with manufacturing procedures and policies, cGMP, and relevant guidelines.
• Generate, execute and/or review completed qualification protocols and associated data for conformance to applicable acceptance criteria.
• Coordinate timely completion of utilities qualification in support of manufacturing activities and Regulatory requirements (writing, reviewing and execution of qualification protocols and reports).

Minimum Requirements:

• Bachelor’s degree Mechanical/ Electrical Engineering /Biotechnology /Biochemistry
• Experience in pharmaceutical industry experience, with at least 3 years in Validation/ Qualification/ Utility support
• Knowledge of HVAC, Water for Injection, Purified Water, Compressed Air and Clean Steam and Nitrogen systems
• Demonstrate ability to provide technical solutions for complex problems through qualification knowledge.
• Proficient in the use of structured problem-solving tools such as Process Mapping, RCA (Root cause analysis), FMEA's (Failure Mode effects analysis) etc.
• In depth understanding of utilities and engineering
• Excellent communication and interpersonal skills
• Ability to work independently
• Overtime from time to time will be required so flexibility will be important.

Core Competencies:

• Relating and networking
• Presenting and communicating information
• Working with people
• Deciding and initiating action
• Delivering results and meeting customer expectations
• Planning and organising
• Writing and reporting
• Applying expertise and technology
• Coping with pressure and setbacks
• Achieving personal work goals and objectives
• Adhering to principles and values