Validation Engineer

Katalyst Healthcares & Life Sciences; Flemington (NJ); On-site; USD 80,000 - 110,000; Full time

Job summary

A leading company in the healthcare and life sciences sector is seeking a qualified individual to manage equipment qualification and validation processes. The role involves developing protocols, supporting equipment qualifications, and ensuring compliance with industry standards. Candidates must possess a BS degree in Engineering or Computer Science and have significant experience in FDA-regulated environments. Strong problem-solving and communication skills are essential for success in a fast-paced, regulatory environment.

Qualifications

• Minimum 5 years of experience in FDA-regulated industry, with 3 years' experience in CSV.
• Strong knowledge of cGXP requirements and 21 CFR Part 11 compliance.
• Excellent understanding of pharmaceutical laboratory and manufacturing systems.

Responsibilities

• Maintains all qualified and validated equipment and systems in compliance.
• Supports calibration and validation activities.
• Manages projects associated with equipment qualification.

Skills

Problem Solving

Attention to Detail

Building Relationships

Multi-tasking

Technical Writing

Communication

Education

BS degree in Engineering / Computer Science

Tools

Microsoft Office Suite

MS Windows client and server technologies

Job description

• 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.
• 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.
• 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.
• Qualifications

  Additional Information

  All your information will be kept confidential according to EEO guidelines.