Senior Validation Engineer – GMP/CSV Lead (Remote)

Jobgether; United States; Remote; USD 110,000 - 125,000; Full time

Benefits offered by this job

Annual base salary 110k–125k USD

Fully remote options

Career development & learning

Flexible working hours

Global teams

Job summary

Jobgether, on behalf of our partner in the United States, is seeking a Senior Validation Engineer to lead validation activities across equipment, utilities, facilities, and computerized systems within GMP contexts. You will develop strategies, write protocols, review reports, and mentor junior engineers while coordinating with Quality and Maintenance teams.

The role offers fully remote work options with occasional site collaboration; strong knowledge of cGMP, FMEA, and CSV is essential for

Qualifications

• Must have a life sciences/engineering background with experience in regulated environments.
• Experience writing and reviewing IQ/OQ/PQ documents and CSV reports.
• Proven ability to lead validation workstreams and mentor junior staff.
• Familiarity with regulatory inspections and audits related to validation.

Responsibilities

• Lead validation lifecycle activities for equipment, utilities, and facilities.
• Develop qualification strategies, protocols, and test methods.
• Prepare summary reports for validation, commissioning, and requalification.
• Collaborate across Engineering, Quality, and Maintenance teams.
• Mentor junior validation engineers and coordinate cross-functional activities.
• Address regulatory findings and support inspections as needed.
• Oversee P&ID walkdowns and thermal mapping activities.

Skills

GxP validation

cGMP knowledge

FMEA

Risk-based validation

CSV validation

IQ/OQ/PQ protocols

Documentation

Leadership

Education

Bachelor’s degree in Life Sciences or Engineering

Tools

CSV software

QA documentation templates

Job description

Jobgether, on behalf of our partner in the United States, is seeking a Senior Validation Engineer to lead validation activities across equipment, utilities, facilities, and computerized systems within GMP contexts. You will develop strategies, write protocols, review reports, and mentor junior engineers while coordinating with Quality and Maintenance teams.

The role offers fully remote work options with occasional site collaboration; strong knowledge of cGMP, FMEA, and CSV is essential for