- Maintains qualified equipment systems in compliance with policies, guidelines and procedures:
- Develops 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.
- Develops written procedures for calibration and preventive maintenance of equipment.
- Supports equipment qualification and validation activities.
- Develops validation/qualification deliverables such as Validation Plans, Requirements
- Specifications, Traceability Matrices, Summary Reports, Change Controls.
- Manages projects of limited scope and complexity within their functional area:
- Supports equipment implementation projects including scheduling, procurement, site prep, installation, qualification, and turn over to business area.
- Supports internal customer groups in the procurement, operation, calibration, and preventive maintenance of equipment to meet business needs in accordance with required schedules or dates.
- Completes all qualification and validation documentation with accuracy, completeness and compliance to Celgene standards.
- Provides excellent customer service and support:
- Regularly reviews, prioritizes and promptly responds to customer equipment qualification and support requests.
- Provides technical support and guidance on equipment qualification issues. Interfaces with customers to ensure all expectations are being met.
- Provides technical support and guidance on equipment and computer systems qualification and validations issues.
- Maintains a positive relationship with all team members and site customers while promoting a positive team environment.
- Regulatory Responsibilities
- Ensure equipment, facilities and programs are maintained in compliance.
- May be called upon as SME in both internal and regulatory audits.
- Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices.
- Experience in the qualification of cell therapy equipment a plus
- Advanced knowledge of pharmaceutical, manufacturing and laboratory systems.
- Understanding of investigations, deviations and CAPA management in a regulated pharmaceutical industry.
- Strong written and verbal communication skills.
- Excellent interpersonal skills with experience dealing with a diverse workforce.
- Strong multi?tasking ability in conjunction with proven organizational skills. 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.
- Highly proficient computer skills in Microsoft Office Suite - Word, Excel, PowerPoint and Outlook with extensive background in database systems. Innate ability to learn new software, such as corporate intranet and enterprise business.
- BS in Engineering or Science related discipline required
- Minimum of 5 years' experience performing/supporting activities in a GMP environment.
- Minimum of 3 years' experience in equipment, facility or utility qualification
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Validation Engineer - Summit, United States - System One Holdings, LLC
Description
Job Title: Validation EngineerLocation: Summit, NJ
Type: Contract
Responsibilities
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
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