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Senior Validation Engineer

TekWissen LLC

Portsmouth, NH • On-site

$35 - $45/hr

Contractor

Re-posted 2 days ago

Job description

Overview:  

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide.   Our client is a leading biotechnology company that combines technological insight with world-class manufacturing, scientific expertise, and process excellence and helps their customers to deliver new and innovative medicines that help treat a wide range of diseases. Our client specializes in pharmaceutical ingredients, Bioscience, Biopharmaceuticals, Custom manufacturing, Biotechnology, Life science ingredients, Nutrition, Microbial Control, Agriculture, Materials Science, Personal Care, and cell and gene therapy.  

Job Title:       Senior Validation Engineer
Location:       Portsmouth, NH - 03801
Duration:       7 Months
Job Type:       Temporary Assignment     
Work Type:   Hybrid
 

Summary
 
The CSV Engineer will act as an individual contributor responsible for ensuring compliance of computerized systems with regulatory requirements and industry standards. The role focuses on implementing best practices, supporting site and process improvement projects, and maintaining GMP-compliant validation and quality systems within a regulated Biotech/Pharma environment.

Responsibilities

  • Act as CSV owner for significant site and process improvement projects, ensuring regulatory compliance and operational efficiency
  • Identify and implement industry best practices using regulatory knowledge and industry networking
  • Collaborate with senior CSV team members during project scoping to identify risks, roadblocks, and efficiency opportunities
  • Perform risk assessments on computerized systems
  • Review and approve change requests, validation test scripts, and protocols
  • Draft, initiate, and review GMP documentation and revisions
  • Execute all aspects of QMS processes including:
  • Change Control (especially related to DCS – DeltaV and MES – Syncade), Deviations, and CAPAs
  • Support validation activities for equipment and computerized systems
  • Perform additional duties as assigned
Required Skills
  • Experience with DeltaV,  Syncade MES
  • Exposure to site-level or large-scale process improvement initiatives
  • Hands-on experience with Distributed Control Systems (DCS) and Manufacturing Execution Systems (MES)
  • Experience performing Change Control, Deviations, and CAPAs in a GMP environment
  • Prior experience leading or supporting projects in Biotech, Pharma, or Biologics industries
  • Strong experience in equipment and/or computerized system validation (CSV)
  • Working knowledge of Controls Automation and Process Control Systems
  • Strong cross-functional collaboration skills
  • Strong attention to detail with the ability to work independently and meet deadlines
TekWissen® Group is an equal opportunity employer supporting workforce diversity.

TekWissen is an emerging global human capital, recruitment and IT services organization. Operating since 2009, we draw upon more than a decade of staffing experience to deliver critical talent acquisition solutions and IT engagements for our clients. We’re founded on a culture that is passionate about delivering tailored solutions, that create lasting partnerships.

Our global footprint covers six countries: United States, Canada, Australia, India, United Kingdom and the Philippines. This allows us to work in close partnership with organizations and manage everything from global talent needs with demanding resourcing strategies, to single sites with lower recruitment volumes.

TekWissen® is an equal opportunity employer supporting workplace diversity. 

TekWissen logo

About TekWissen

Sourced by ZipRecruiter

TekWissen is an emerging global human capital, recruitment and IT services organization. Operating since 2009, we draw upon more than a decade of staffing experience to deliver critical talent acquisition solutions and IT engagements for our clients. We’re founded on a culture that is passionate about delivering tailored solutions, that create lasting partnerships.

Industry

Recruiting and staffing services

Company size

501 - 1,000 Employees

Headquarters location

Ann Arbor, MI, US

Year founded

2009

Social media

Twitter

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