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Validation Engineer

1 month ago

Summit, United States TSR Consulting Full time
About TSR:

TSR is a relationship-based, customer-focused IT and technical services staffing company.

For over 40 years TSR, Inc. and its wholly owned subsidiary, TSR Consulting Services, have prospered in the Information Technology staffing business, earning the respect of companies both large and small with well refined candidate screening, timely placement, and a real understanding of the right skill sets required by our clients.

Mission & Vision

We do not believe in building a vision around the company but building a company around our vision, which is simply;

Every employee's voice matters, their effort is appreciated, and their talent is rewarded.

We challenge each employee daily, to raise the bar on how we treat our consultants and candidates. For far too long in this industry, candidates have been ghosted, lied to, or placed at a client and then forgotten about. Each day our staff works tirelessly at qualifying and placing, top talent with our clients, in a compassionate and caring manner.

Not every candidate is a match for the job, but every candidate and consultant will be treated with respect and professionalism.

Validation Engineer

Job Description

  • Location: Summit, New Jersey
  • Type: Contract
  • Job #79916
Our client, a leading pharmaceutical company, is hiring a Validation Engineer, on a contract basis.

Job ID #: 79916

Work Location:
Summit, NJ - 50% on site

Summary:
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 scope. 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.

Knowledge/Skills:
  • Technical / Professional Knowledge
  • Problem Solving / Troubleshooting
  • Action Oriented
  • Attention to Detail
  • Multi-tasking
  • Building Relationships
Education/Experience:
  • Required BS degree in Engineering / Computer Science
  • 5 years of experience in FDA-regulated industry, with min 3 years' experience in CSV
  • 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.
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.