Title: Validation Engineer
Duration: 6 Months
Location: Summit, NJ 07901
Job Description:
- The Validation Engineer supports the successful implementation of laboratory/process equipment at multi-use sites through interaction with internal customers and external service providers.
- The incumbent in this role, contributes to the completion of milestones associated with equipment qualification.
- With minimum supervision and given general instructions, this individual carries out routine tasks and functions, and uses basic analytical skills to recognize and solve common problems of limited scope. As a developing team player, the incumbent interacts with their immediate supervisor and personnel within their own work group to achieve team goals while building trust and collaborative relationships outside the immediate organization.
Essential Functions:
- Reviews qualification protocols, and associated reports while adhering to a change management process.
- Supports the execution of equipment qualifications and validation protocols
- Supervises vendors for qualification functions.
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- Provides excellent customer service and support.
- Maintains a positive relationship with all team members and site customers while promoting a positive team environment.
- Required Competencies-Knowledge, Skills, and Abilities:
- Knowledge, Skills & Abilities:
- Excellent understanding of cGXP requirements and good documentation practices relating to systems, equipment and instrumentation within the pharmaceutical industry
- Familiarity with 21 CFR Part 11 compliance
- Knowledge of pharmaceutical laboratory and process systems. Preferred experience with Biologics equipment.
- Experience executing equipment qualification documents
- Ability to interact effectively with laboratory, QA, and Facilities groups
- 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 and Outlook, and the ability to learn new software as required for equipment qualification.
Competencies:
- Technical / Professional Knowledge
- Problem Solving / Troubleshooting
- Action Oriented
- Attention to Detail
- Multi-tasking
- Building Relationships
Education & Experience:
- BS degree in Engineering or equivalent
- Minimum 5 years of experience in FDA-regulated industry, with 3 year experience in equipment qualification.
Working Conditions:
Environmental Conditions:
- Environment may include working in office or in a laboratory / manufacturing area.
- Ability to work safely in an environment with hazardous, radioactive, and infectious materials and waste.
- Ability to work safely when working alone, or working with others.
Thanks & Regards
Anil
Resource specialist
732-934-4269
anilkumar@intellectt.com
Intellectt Inc