Lead QC Validation Engineer – Onsite Biopharma

avidbio; Tustin (CA); On-site; USD 105,000 - 124,000; Full time

Benefits offered by this job

Health, Dental, and Vision Insurance

401(k) matching

Paid time off

Job summary

Avid Bioservices is seeking a Lead Engineer, Quality Control to provide validation support for new and upgraded QC equipment, processes, and software. You will serve as the primary QC interface for validations and facilities.

You will lead select Capex/Opex projects, manage equipment validation, write URS and protocol documents, and ensure deviations are addressed in a compliant, timely manner. This onsite role offers competitive compensation and benefits.

Qualifications

• BA/BS in Science or related field with 4-5 years in biopharma/manufacturing including validations.
• Strong knowledge of GMP, 21 CFR Part 11 and GAMP.
• Experience writing and managing URS, IQ/OQ/PQ, and validation reports.

Responsibilities

• Lead QC validation projects, including planning, budgeting, and execution.
• Plan and procure new QC equipment and coordinate lab movements.
• Write and review validation documents, URS, and protocols; manage deviations.

Skills

Quality Control Validation

GMP Compliance

Process Validation

Project Management

Documentation Standards

Education

BA/BS in Science

Tools

Validation Protocols (IQ/OQ/PQ)

Job description

Avid Bioservices is seeking a Lead Engineer, Quality Control to provide validation support for new and upgraded QC equipment, processes, and software. You will serve as the primary QC interface for validations and facilities.

You will lead select Capex/Opex projects, manage equipment validation, write URS and protocol documents, and ensure deviations are addressed in a compliant, timely manner. This onsite role offers competitive compensation and benefits.