Equipment Validation Engineer

TekWissen LLC

Vacaville, CA

JOB DETAILS
SALARY
$30–$35
SKILLS
Agriculture, Biology, Biotech and Pharmaceutical, Communication Skills, Continuous Improvement, Corporate Policies, Corrective Action, Cost Effectiveness Analysis, Cross-Functional, Current Good Manufacturing Practice (cGMP), Customer Support/Service, Disease, Diversity, Equipment Validation, Establish Priorities, Gene Therapy, Laboratory Equipment, Laboratory Operations, Maintain Compliance, Manufacturing, Material Science, Medical Products, Nutrition, Operational Support, Organizational Skills, Personal Care, Presentation/Verbal Skills, Problem Solving Skills, Quality Control, Quality Metrics, Regulations, Regulatory Compliance, Regulatory Requirements, Requirements Management, Team Player, Workforce Management, Writing Skills
LOCATION
Vacaville, CA
POSTED
2 days ago
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: Equipment Validation Engineer
Location: Vacaville, CA - 95688
Duration: 12 Months
Job Type: Temporary Assignment
Work Type: Onsite
Shift: Monday to Friday from 08:00 AM to 05:00 PM
Summary
The Validation Engineer / Equipment Validation Engineer supports and executes QC laboratory equipment qualification activities under direct supervision. Ensure full compliance with current cGMP regulations and Roche/Genentech quality standards, policies, and core values. Maintain operational readiness, product supply continuity, and cost-effectiveness through participation in continuous improvement initiatives.

Responsibilities
  • Perform laboratory equipment qualification activities according to established equipment qualification (EQ) policies, plans, and procedures.
  • Collaborate with laboratory personnel to define equipment qualification requirements.
  • Author, review, and execute equipment qualification protocols.
  • Coordinate qualification activities with equipment vendors and internal support groups.
  • Identify business, quality, and compliance gaps and support corrective actions.
  • Review and sign qualification-related documents as authorized by company policies and procedures.
  • Support QC laboratory operations through additional assignments as requested by senior management.
  • Participate in continuous improvement projects to enhance laboratory efficiency and compliance.
Required Skills
  • Bachelor's degree (BS/BA), preferably in a scientific discipline.
  • Experience in the pharmaceutical, biopharmaceutical, or related regulated industry.
  • Minimum 2 years of experience in equipment qualification and/or validation (preferred).
  • Knowledge of cGMP regulations or equivalent regulatory requirements.
  • Equipment qualification and validation execution.
  • Protocol authoring, review, and execution.
  • Regulatory compliance and cGMP knowledge.
  • Gap assessment and compliance monitoring.
  • Coordination with vendors and cross-functional teams.
  • Strong verbal and written communication skills.
  • Ability to influence stakeholders across different organizational levels.
  • Relationship-building and collaboration skills.
  • Strategic thinking with the ability to translate plans into actions.
  • Strong organizational and prioritization skills.
  • Sound decision-making and problem-solving abilities.
  • Flexibility to adapt to changing priorities and business needs.
  • Results-oriented mindset with accountability for outcomes.
TekWissen Group is an equal opportunity employer supporting workforce diversity.

About the Company

T

TekWissen LLC

WE THE TEKWISSEN PEOPLE

TekWissen offers you a broader portfolio of services, industry-leading solutions, and the meaningful innovations that give you greater flexibility and speed to respond to market dynamics, reduced costs and risk to improve enterprise performance, and increased productivity to enable growth.

To keep pace with global market demands, TekWissen keeps its finger on the pulse of change. Our organized approach to guiding a project from its inception to closure. Managing projects is becoming more and more important as we enter the digital era. To cope with the pace that this transition demands, a method is required to manage projects so they can yield quality work, while incorporating efficient use of time and resources.

Project involves identifying which quality standards are relevant to the project and determining how to satisfy them.

It is important to perform quality planning during the Planning Process and should be done alongside the other project planning processes because changes in the quality will likely require changes in the other planning processes, or the desired product quality may require a detailed risk analysis of an identified problem. It is important to remember that quality should be planned, designed, then built in, not added on after the fact.

Capabilities and accomplishments in one TekWissen business enhance the opportunity for success in the others. Put simply, TekWissen's unique combination of attributes promotes success.



COMPANY SIZE
100 to 499 employees
INDUSTRY
Computer/IT Services
FOUNDED
2009
WEBSITE
http://www.tekwissen.com/