Validation Engineer

Job Description

Top Skills:

5+ years of Computer system validation experience

5+ years of experience in 21CFR P11 compliance regulations

Good understanding of Audit Trail

Experience on troubleshooting issues related to compute systems validation.

Experience working on deviations

Knowledge, Skills & Abilities:

• Strong working knowledge of MS Windows client and server technologies.

• Working knowledge of standard networking principles and technologies

• Excellent understanding of cGXP requirements and good documentation practices relating to systems, equipment and instrumentation within the pharmaceutical industry

• Strong working knowledge of ISPE guidance and 21 CFR Part 11 compliance

• Ability to work with the end user to identify and document User and Functional Requirements

• Knowledge of pharmaceutical laboratory and manufacturing systems.

• Experience executing equipment qualification documents

• Ability to interact effectively with laboratory, QA, and Facilities groups

• Strong ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously

• Strong written and verbal communication skills along solid presentation skills. Proficient at writing well-formulated emails and reports. Ability to follow oral and written instructions, read and interpret engineering manuals/drawings relevant to the assigned task. Ability to effectively communicate with employees, contractors and vendors. Experience with technical writing and document development / generation

• Strong computer skills in Microsoft Office Suite – Word, Excel, Visio and Outlook, and the ability to learn new software as required for equipment qualification.Company Description

Founded in 2015 and backed by two decades of hands-on experience, our strong insight on the enterprise ecosystem and its dynamics helps to offer a complete end-to-end solution. We automate recruitment processes with intelligent solutions to save time and money. Synkriom leads the industry with experience authentication of candidates.