PV Process Engineer | GMP & CDMO Oversight

Verista; Novato (CA); On-site; USD 85,000 - 127,000; Full time

Benefits offered by this job

High growth potential

Competitive pay and incentives

Medical, Dental & Vision

401(k) Retirement Plan

Paid Time Off and holidays

Tuition reimbursement

Job summary

Verista in the United States is seeking a Process Engineer to lead PV protocol development and qualification activities within GMP-regulated environments. You will coordinate sampling plans, testing, data collection, and reporting across Manufacturing, Quality, and external CDMOs to keep timelines on track.

Ideal candidates have 2-5 years in MSAT or process engineering, strong technical writing skills, and proven ability to manage cross-functional projects while maintaining regulatory compliance

Qualifications

• Bachelor’s degree in engineering or life sciences required.
• 2–5 years of experience in MSAT, process engineering, or manufacturing within GMP-regulated settings.
• Experience with CDMO or vendor oversight is valuable; includes coordinating sampling and data collection.

Responsibilities

• Meet with stakeholders and SMEs to gather input and develop PV protocols.
• Coordinate execution of PV protocols, including sampling plans, testing, data tracking, and data collection.
• Partner with Manufacturing, Quality, QC, MSAT and external CDMOs to keep sampling, testing, and reporting on schedule.
• Provide day-to-day oversight of vendor and CDMO PV activities, tracking milestones and deliverables.
• Track and compile PV data, review for completeness, flag trends, and escalate issues.
• Support deviations and discrepancies resolution during protocol execution.
• Summarize PV results in final reports and prepare final packages for SME review.
• Maintain trackers and ensure activities comply with GMP and regulatory requirements.

Skills

MSAT experience

Process engineering

GMP environment

Technical writing

Project management

Cross-functional collaboration

Education

Bachelor's degree in Engineering (Chemical, Biomedical, Biochemical, or similar), Life Sciences, or a related technical field

Job description

Verista in the United States is seeking a Process Engineer to lead PV protocol development and qualification activities within GMP-regulated environments. You will coordinate sampling plans, testing, data collection, and reporting across Manufacturing, Quality, and external CDMOs to keep timelines on track.

Ideal candidates have 2-5 years in MSAT or process engineering, strong technical writing skills, and proven ability to manage cross-functional projects while maintaining regulatory compliance