Validation Engineer

Katalyst CRO; Warren Grove (NJ); On-site; USD 66,000 - 125,000; Full time

Job summary

Katalyst CRO is seeking a dedicated Validation Engineer to join their quality assurance team. The successful candidate will manage the qualification and validation processes for equipment and computerized systems in a FDA-regulated environment. This role requires a strong engineering background, experience in a regulated industry, and excellent communication skills. If you are driven and ready to contribute to a collaborative team, apply now.

Qualifications

• 5 years of experience in FDA-regulated industry; 3 years in CSV.
• Strong understanding of cGXP requirements and related documentation.
• Experience executing equipment qualification documents.

Responsibilities

• Maintain qualified and validated equipment according to policies.
• Develop validation/qualification deliverables like Validation Plans.
• Supervise vendors for qualification functions.

Skills

Attention to Detail

Problem Solving

Multi-tasking

Building Relationships

Action Oriented

Education

BS degree in Engineering / Computer Science

Tools

Microsoft Office Suite

MS Windows client and server technologies

Job description

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Responsibilities

Maintains all qualified and validated equipment and systems in compliance with policies, guidelines and procedures.

Responsibilities

Maintains all qualified and validated equipment and systems in compliance with policies, guidelines and procedures.

Develops 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.

Supports calibration, equipment qualification and validation activities.

Configures and documents the configuration of computerized systems.

Develops validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports, and Change Controls.

Manages projects of varying scope and complexity.

Supports laboratory and manufacturing equipment implementation projects including scheduling, procurement, site prep, installation, qualification, and turn over to business area.

Independent ownership of all lifecycle deliverables in the Qualification of equipment and full CSV for single and multi-user Computerized Systems.

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 Company 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 calibration and equipment qualification issues. Interfaces with customers to ensure all expectations are being met.

Maintains a positive relationship with all team members and site customers while promoting a positive team environment.

Requirements

Required BS degree in Engineering / Computer Science.

Minimum 5 years of experience in FDA-regulated industry, with 3 years' experience in CSV.

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.

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.

Technical / Professional Knowledge.

Problem Solving / Troubleshooting.

Action Oriented.

Attention to Detail.

Multi-tasking.

Building Relationships.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Biotechnology Research and Civil Engineering

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