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Validation Engineer
1 month ago
Job Title: Validation Engineer
Job Location: Summit NJ
Duration: 06+ months contract position (high possibility of extension)
Job Description: 100% Onsite position
NOTE- Temperature Mapping Experience is a Must
Only W2.
PURPOSE AND Product OF POSITION:
• The Equipment Validation Engineer supports the successful implementation of various process/lab equipment at multi-use sites through interaction with internal customers and external service providers. The incumbent in this is tasked with commissioning and qualifying new equipment.
• facilities, utilities and maintaining equipment systems in a qualified/validated state according to established policies and procedures. The individual participates in projects and ongoing work.
• activities of low to moderate complexity. 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 Product. 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.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
· 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.
Education and Experience:
• 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
DUTIES AND RESPONSIBILITIES:
• 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.
• Develop validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports, and Change Controls.
• Manages projects of limited Product and complexity within their functional area: Supports equipment implementation projects including scheduling, procurement, site prep, installation, qualification, and turnover to the 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 Client standards.
• Provide 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 validation issues.
• Maintains a positive relationship with all team members and site customers while promoting a positive team environment.
