Computer System Validation Specialist

2 months ago

Norwood, Massachusetts, United States DPS Group Global Full time

Position Overview

DPS Group is in search of a motivated and skilled Computer System Validation Engineer. This role focuses on the validation of IT systems for a continuous manufacturing environment. The engineer will provide expertise in IT systems validation and compliance for newly implemented IT and digital solutions. Strong communication and interpersonal skills are essential, along with the ability to work independently. Familiarity with IT systems, CSV, ValGenesis, project management, and EQMS is highly desirable.

Key Responsibilities

  • Oversee the Computer System Validation processes for IT projects from software installation through to business release.
  • Collaborate with service providers and IT teams to ensure successful software installations and configurations.
  • Manage server installations and system-related tasks, including security settings, administrative configurations, and access permissions.
  • Create computer system validation documentation in compliance with site procedures and GMP standards.
  • Execute test scripts, analyze results, and assess acceptability against predefined criteria.
  • Work with business units to identify and implement procedural controls to address issues identified during testing.
  • Initiate and manage Change Control activities in line with Quality Standards and Practices, proposing solutions or recommendations for enhancements.
  • Prioritize validation tasks according to project timelines.
  • Engage with global IT and Quality teams for collaborative efforts.
  • Adhere to all relevant Environmental, Health, and Safety protocols and assist in incident investigations as necessary.
  • Review and approve vendor-generated computer system validation documentation.

Additional Requirements

To excel in this role, candidates must demonstrate the ability to fulfill essential duties effectively. The following qualifications are indicative of the knowledge, skills, and abilities required:

  • Continuous Learning: Self-assess strengths and weaknesses, pursue development opportunities, and seek feedback for performance improvement.
  • Culture: Foster a culture of excellence and contribute to a collaborative environment that values teamwork and mentorship.
  • Customer Service: Exhibit courtesy and sensitivity in managing customer interactions and commitments.
  • Planning and Organizing: Efficiently prioritize and plan work activities, integrating changes smoothly.
  • Teamwork: Balance individual and team responsibilities, contributing to a positive team spirit.
  • Use of Technology: Demonstrate proficiency in required skills and adapt to new technologies.
  • Language Ability: Read and interpret technical documents and communicate effectively.
  • Mathematical Ability: Apply mathematical concepts to practical situations.
  • Reasoning Ability: Utilize common sense to follow instructions and address problems.

About DPS Group

DPS Group is a global EPCMV firm providing comprehensive solutions in the Life Sciences (pharmaceutical, biotechnology, and medical technology) and Advanced Technology (semiconductor, data center, and solar) sectors. DPS is committed to delivering successful projects with a client-centric approach across various market sectors, including Project and Program Management, Procurement, Design, Construction Management, Health and Safety Management, Commissioning, Qualification, and Start-up.

DPS Engineering Inc. is an Equal Opportunity Employer. Employment decisions are based on merit, qualifications, and abilities without discrimination based on race, color, religion, gender, national origin, age, sexual orientation, gender identity, disability, veteran status, or any other characteristic protected by law.

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