GMP Process Engineer | PV & PPQ Specialist

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

Benefits offered by this job

Life Insurance

Disability Insurance

Health Savings Account

Paid Time Off

Tuition Reimbursement

Parental Leave

Job summary

Verista, Inc. is expanding its Process Engineering team in the US, offering a role focused on process validation (PV) activities within GMP-regulated environments.

You will lead development and execution of PV protocols, coordinate sampling plans, and partner with internal and external teams to ensure timely data collection and reporting. The ideal candidate has a background in chemical/biomedical engineering or life sciences, with 2–5 years in MSAT or manufacturing processes, strong technical

Qualifications

• Requires a Bachelor’s degree in Engineering, Life Sciences, or related technical field.
• 2–5 years in MSAT, process engineering, or GMP-regulated environments.
• Knowledge of PV protocols, PPQ, and sampling/testing strategies.
• Experience with CDMOs or vendor oversight is valuable.
• Strong writing, organization, and collaboration skills.

Responsibilities

• Meet with stakeholders and SMEs to develop PV protocols.
• Coordinate execution of PV protocols, sampling plans, testing and data collection.
• Collaborate with Manufacturing, Quality, MSAT and external partners to stay on schedule.
• Oversee vendor and CDMO PV activities, track milestones and risks.
• Compile PV data, review for completeness and flag trends.
• Support deviations and discrepancies resolution during protocol execution.
• Summarize protocol execution and prepare final reports for SME review.

Skills

PV protocols

PPQ

Sampling strategies

CDMO/vendor oversight

Project management

Technical writing

Cross-functional collaboration

Education

Bachelor's degree in Engineering/ Life Sciences

Job description

Verista, Inc. is expanding its Process Engineering team in the US, offering a role focused on process validation (PV) activities within GMP-regulated environments.

You will lead development and execution of PV protocols, coordinate sampling plans, and partner with internal and external teams to ensure timely data collection and reporting. The ideal candidate has a background in chemical/biomedical engineering or life sciences, with 2–5 years in MSAT or manufacturing processes, strong technical