What are the responsibilities and job description for the Validation Engineer position at eTeam?
Validation Engineer/QC Laboratory Equipment Qualification Specialist
Location: Vacaville, CA, 95688 - Onsite (5 Days/Week)
Schedule: Monday–Friday, 8:00 AM–4:00 PM (30-minute unpaid lunch)
Contract Opportunity
Job Summar
yWe are seeking a QC Laboratory Equipment Qualification Specialist to support qualification and validation activities for laboratory equipment in a regulated cGMP environment. This role will be responsible for coordinating, authoring, reviewing, and executing equipment qualification protocols while ensuring compliance with quality and regulatory requirements. The ideal candidate will have experience in pharmaceutical, biopharmaceutical, or biotechnology environments and a strong understanding of equipment qualification processes
.
Responsibilities:
- Execute laboratory equipment qualification activities in accordance with established procedures and quality standards.
- Author, review, and execute qualification protocols, including IQ, OQ, and PQ documentation.
- Partner with laboratory personnel and cross-functional teams to define qualification requirements.
- Coordinate qualification activities with vendors and internal support groups.
- Support compliance initiatives by identifying quality, business, and regulatory gaps.
- Maintain accurate qualification records and documentation.
- Participate in continuous improvement initiatives supporting QC laboratory operations.
- Ensure activities are performed in compliance with cGMP requirements and internal quality systems.
Required Qualification:
- Bachelor’s degree in a scientific discipline or related field.
- 2 years of experience in Equipment Qualification, Validation, CQV, or related activities within a regulated environment.
- Experience working in pharmaceutical, biopharmaceutical, biotechnology, or medical device industries.
- Knowledge of cGMP, GMP, GLP, or GxP regulations.
- Experience with IQ/OQ/PQ protocol development and execution.
- Strong documentation, communication, and organizational skills.
- lAbility to manage multiple priorities and work effectively in a cross-functional environment.
Preferred Qualifications:
- Experience supporting QC laboratories or analytical laboratory equipment.
- Familiarity with deviations, CAPA, change controls, and quality systems.
- Experience coordinating vendors and qualification service providers.
- Strong problem-solving and continuous improvement mind set.