Senior Validation Engineer — GMP & Compliance Lead

JobDiva, Inc.; Fort Washington (Montgomery County); On-site; USD 110,000 - 170,000; Full time

Job summary

JobDiva, Inc. is seeking an experienced Senior Validation Specialist to lead qualification and validation activities in a GMP-regulated environment for equipment, facilities, utilities, processes, and computerized systems.

You will ensure compliance with FDA, EMA, and cGMP requirements, write and review validation protocols and reports, and mentor junior engineers. Collaborating with Engineering, Quality Assurance, Manufacturing, Automation, and Regulatory teams, you will drive validation

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Biotechnology, Pharmacy, Chemistry, or related field.
• 5+ years of validation experience in a GMP-regulated environment.
• Experience with FDA/EMA guidelines and 21 CFR Part 11.

Responsibilities

• Lead validation lifecycle activities including DQ, IQ, OQ, and PQ.
• Author, review, and approve validation protocols, reports, risk assessments, and plans.
• Execute equipment, process, cleaning, utility, facility, and CSV validation activities.
• Support commissioning and qualification (C&Q) activities for new equipment and systems.
• Manage deviations, investigations, CAPAs, and change controls related to validation.
• Develop and maintain Validation Master Plans (VMPs).
• Ensure compliance with cGMP, GxP, FDA, EU GMP, and data integrity requirements.
• Support regulatory inspections and internal/external audits.
• Collaborate with Engineering, QA, Manufacturing, Automation, and Regulatory teams.
• Mentor junior validation engineers and specialists.

Skills

Validation lifecycle

IQ/OQ/PQ

CSV/validation

Risk assessments

Change Control/CAPA

Regulatory compliance

Documentation/writing

Education

Bachelor's degree in Engineering or Life Sciences

Tools

Kneat

ValGenesis

TrackWise

MasterControl

Job description

JobDiva, Inc. is seeking an experienced Senior Validation Specialist to lead qualification and validation activities in a GMP-regulated environment for equipment, facilities, utilities, processes, and computerized systems.

You will ensure compliance with FDA, EMA, and cGMP requirements, write and review validation protocols and reports, and mentor junior engineers. Collaborating with Engineering, Quality Assurance, Manufacturing, Automation, and Regulatory teams, you will drive validation