Validation Engineer

Creative Solutions Services, LLC; Vacaville (CA); On-site; USD 59,000 - 84,000; Full time

Benefits offered by this job

Weekly pay

Healthcare benefits

Job summary

Creative Solutions Services, LLC is hiring a Validation Engineer for an onsite role in Vacaville, CA. The position is a 12+ month contract with potential for extension or permanent placement, Monday–Friday, 8:00 AM–4:00 PM.

Pay rate is $52/hour based on experience, with weekly pay and healthcare benefits offered. The role involves performing qualification of laboratory equipment under cGMP guidelines, coordinating with lab staff and vendors, and producing qualification documentation to support

Qualifications

• BS/BA in a relevant scientific discipline is required.

Responsibilities

• Perform qualification of laboratory equipment in accordance with EQ policies, plans, and procedures.
• Coordinate with laboratory personnel to define qualification requirements.
• Author, review, and execute equipment qualification protocols.
• Coordinate equipment qualification activities with vendors and other support groups.
• Identify business, quality, and compliance gaps.
• Sign documents for activities as authorized and described by client's policies, procedures, and job descriptions.
• Perform any other tasks as requested by Senior Management to support QC laboratory operations.

Skills

Verbal communication

Written communication

Influence

Relationship building

Strategic thinking

Accountability

Education

BS/BA in a relevant science

Job description

Up to $52.30 per hour Vacaville, CA Onsite

Job Description

Role: Validation Engineer - Onsite

Location: 1000 New Horizons Way, Vacaville, CA 95688

Contract: 12+ months contract with potential for extension and/or permanent placement

Schedule:Monday – Friday, 8:00 AM – 4:00 PM (includes a 30-minute unpaid lunch)

Pay Rate: $52/hour, based on experience

Benefits: Weekly pay and healthcare benefits offered!

Job Summary

With direct supervision, the candidate is responsible for the support and execution of QC laboratory equipment qualification activities while in full compliance with current cGMP regulations and client'scorporate principles, quality policies, standards, and core values. Maintains the company's right to operate, supply to patients, and cost-effectiveness by actively participating in continuous improvement projects.

Duties

Technical Responsibilities

• Perform qualification of laboratory equipment in accordance with EQ policies, plans, and procedures.
• Coordinate with laboratory personnel to define qualification requirements.
• Author, review, and execute equipment qualification protocols.
• Coordinate equipment qualification activities with vendors and other support groups.
• Identify business, quality, and compliance gaps.
• Sign documents for activities as authorized and described by client'spolicies, procedures, and job descriptions.
• Perform any other tasks as requested by Senior Management to support QC laboratory operations.

Job Requirements

Education

• BS/BA degree (preferably in a relevant scientific discipline).

Experience

• Experience in the pharmaceutical/biopharmaceutical industry, or an equivalent combination of education and experience.
• Knowledge of cGMP or equivalent regulations.
• Minimum of two years' experience in Validation or equipment qualification is desired.
• Ability to make sound decisions about scheduling and managing priorities.
• Flexibility in problem-solving, providing direction, and work hours to meet business objectives.

Knowledge / Skills / Competencies

• Possesses strong verbal and written communication skills and the ability to influence at all levels.
• Capable of building trustful and effective relationships.
• Able to think strategically and translate strategies into actionable plans.
• Takes responsibility, drives results, and achieves expected outcomes.

Work Environment / Physical Demands / Safety Considerations

Standard office environment.