Validation Engineer

Cynet Systems Inc; Summit (NJ); On-site; USD 125,000 - 150,000; Full time

Job summary

Join a forward-thinking company that specializes in the pharmaceutical industry, where you will play a crucial role in maintaining and validating essential equipment and systems. This exciting position requires expertise in compliance with cGXP requirements and a strong technical background in engineering or computer science. You will manage projects, develop protocols, and ensure all documentation meets company standards. If you thrive in a dynamic environment and enjoy problem-solving while working with diverse teams, this opportunity is perfect for you. Be part of a team that values excellence and innovation in a challenging yet rewarding setting.

Qualifications

• 5+ years of experience in FDA-regulated industry with CSV expertise.
• Strong knowledge of cGXP requirements and documentation practices.

Responsibilities

• Maintains qualified and validated equipment in compliance with policies.
• Supports equipment qualification and validation activities.
• Develops validation/qualification deliverables and manages projects.

Skills

MS Windows client and server technologies

Networking principles and technologies

cGXP requirements

21 CFR Part 11 compliance

User and Functional Requirements documentation

Pharmaceutical laboratory and manufacturing systems

Equipment qualification documents

Organizational skills

Written and verbal communication

Technical writing

Education

BS degree in Engineering / Computer Science

Tools

Microsoft Office Suite (Word, Excel, Visio, Outlook)

Job description

Job Description:

Pay Range: $69.72hr - $88.55hr

Essential Functions:

• 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 equipment qualification and systems validation activities.
• Configures and documents the configuration of computerized systems
• Develops validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports, 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.

Required Competencies-Knowledge, Skills, and Abilities:
Knowledge, Skills And Abilities:

• 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.

Competencies:

• Technical / Professional Knowledge.
• Problem Solving / Troubleshooting.
• Action Oriented.
• Attention to Detail.
• Multi-tasking.
• Building Relationships.

Education And Experience:

• Required BS degree in Engineering / Computer Science or any related field.
• Minimum 5 years of experience in FDA-regulated industry, with 5 years experience in CSV.

Working Conditions:
Environmental Conditions:

• 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.