Validation Engineer

Integrated Resources, Inc.; Summit (NJ); Hybrid; USD 90,000 - 120,000; Full time

Job summary

A leading company in the pharmaceutical industry is seeking a CSV Engineer to support the implementation of manufacturing and laboratory equipment. This hybrid role involves maintaining compliance, developing protocols, and managing equipment qualifications. The ideal candidate will have strong technical knowledge, excellent communication skills, and experience in FDA-regulated environments.

Qualifications

• Minimum 5 years of experience in FDA-regulated industry.
• Experience executing equipment qualification documents.
• Strong written and verbal communication skills.

Responsibilities

• Supports equipment qualification and systems validation activities.
• Develops protocols and associated reports.
• Maintains all qualified and validated equipment.

Skills

Problem Solving

Attention to Detail

Building Relationships

Education

BS degree in Engineering / Computer Science

Tools

Microsoft Office Suite

MS Windows

Job description

Description

Hybrid Role- 50% onsite minimum required

Position Overview:

The CSV Engineer supports the successful implementation of manufacturing and laboratory equipment and computerized systems at multi-use sites through interaction with internal customers and external service providers. The incumbent in this role, contributes to the completion of milestones associated with equipment qualification and systems validation. 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.

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 Product 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 & 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 & 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.