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Validation Engineer

Organization

TriLink Biotechnologies

Job Location

10770 Wateridge Circle, Ste 200
San Diego, CA 92121
United States

Job Description

Validation Engineer

TriLink BioTechnologies is actively responding to the COVID-19 pandemic through vaccine and diagnostic programs.

TriLink BioTechnologies, a Maravai LifeSciences company, is seeking a Validation Engineer to join our growing team.   The Validation Engineer is responsible for major equipment and process validation for the manufacturing facilities to meet current GMP and industry standards.

Responsibilities

  • Responsible for maintaining major equipment in a state of validation, such as HVAC, water systems (DI and Polishers), air pressure systems including nitrogen and clean air, Re-validation Program, Process equipment, etc
  • Responsible for the establishment and execution of validation protocols
  • Maintains up-to-date knowledge of validation requirements, practices, and procedures across the industry
  • Interfaces with departmental equipment owners and coordinates activities of validation when required
  • Interacts with all parts of the organization to facilitate protocol execution as necessary
  • Complies with Health, Safety and Environmental responsibilities applicable to the position
  • Understands facility drawings, equipment diagrams, and maintenance procedures
  • Works with TriLink’s facility, engineering, and manufacturing groups to develop validation strategies, plans, protocols, and reports
  • Works with Quality Control  to establish procedures for analysis of environmental monitoring data and development of summary reporting/trending program
  • Demonstrates excellent interpersonal skills, including the ability to resolve conflicts using poise, diplomacy, and tact and the ability to interact with people of a wide variety of backgrounds, levels of responsibility, and education levels
  • Applies expertise in current validation requirements set forth by the FDA and other industry standards to develop and implement compliant validation strategies

Qualifications

  • BS Degree or equivalent in a scientific discipline
  • A minimum of 2 years experience in a related field of work within the biotech or pharmaceutical industry
  • familiarity with FDA regulated biotechnology or drug validation requirements
  • Experience executing facility, equipment, and computer validation projects for biotech or pharmaceutical production projects
  • Must be knowledgeable in FDA and cGMP and related regulations and guidelines. 
  • Must have specific knowledge of validation methodologies, techniques, and principles
  • Strong ability to maintain state-of-the-art skills

TriLink BioTechnologies is a rapidly growing biotech firm in San Diego, CA that offers competitive wages and a full benefits package including medical, dental, vision, LTD, and a retirement plan.

 

TriLink BioTechnologies is an EEO employer.

 

 

 

About Our Organization

TriLink BioTechnologies, a Maravai LifeSciences company, offers mRNA and oligo solutions as comprehensive CDMO services and an expansive stocked menu - to accelerate research, diagnostic, and therapeutic applications. TriLink has paved the way with industry-leading technology, consistently high quality, and ready access to expert scientific support. 

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