Validation Engineer/Specialist (Hybrid Summit NJ)
We are looking for a Validation Engineer/Specialist for a global pharmaceutical Company. This role will support Lab and Manufacturing equipment in the areas of calibration qualification and validation. Projects will include implementation projects including scheduling procurement site prep installation qualification and turnover to the business area.
This is a 40hour perweek 12month contract hybrid (50% onsite) role in Summit NJ.
This is a W2 role as a Stage 4 Solutions employee. Health benefits and 401K are offered.
Responsibilities:
- Maintains all qualified and validated equipment and systems in compliance with policies guidelines and procedures.
- Support Lifecycle Document Management System
- Develops protocols and associated reports while adhering to a change management process.
- Supports the of equipment qualifications and validation protocols
- Supervises vendors for qualification functions.
- Develops written procedures for calibration and preventive maintenance of equipment
- Supports calibration equipment qualification and validation activities.
- Configures and documents the configuration of computerized systems
- Develop validation/qualification deliverables such as Validation Plans Requirements Specifications Traceability Matrices Summary Reports and Change Controls.
- Supports laboratory and manufacturing equipment implementation projects including scheduling procurement site prep installation qualification and turnover to the business area.
- Independent ownership of all lifecycle deliverables in the Qualification of equipment and full CSV for single and multiuser Computerized Systems
- Supports internal customer groups in the procurement operation calibration and preventive maintenance of equipment to meet business needs by required schedules or dates.
- Completes all calibration qualification and validation documentation with accuracy completeness and compliance with Celgene standards.
- Provides technical support and guidance on calibration and equipment qualification issues. Interfaces with customers to ensure all expectations are being met.
Requirements:
- 2 years of experience working with Equipment commissioning and validation in the Pharmaceutical Industry.
- Experience executing qualification documents
- Ability to interact effectively with laboratory QA and Facilities groups
- Strong computer skills in Microsoft Office Suite Word Excel Visio and Outlook
- Bachelors Degree in Engineering/Computer Science
Please submit your resume to our network at (please apply to the Validation Engineer/Specialist (Hybrid Summit NJ) role).
Please feel free to forward this project opening to others who may be interested.
Stage 4 Solutions is an equal opportunity employer. We celebrate diversity and are committed to providing employees with an inclusive environment that is free of discrimination and harassment. All employment decisions are based on the job requirements and candidates qualifications without regard to race color religion/belief national origin gender identity age disability marital status genetic information or other applicable legally protected characteristics.
Compensation: $42/hr $44/hr.