Description

You will own verification deliverables and validation protocols for key capital projects within a regulated manufacturing environment.

Responsibilities

• Lead verification deliverables and identify critical quality parameters for new equipment or facility modifications.
• Oversee the development and execution of validation protocols in compliance with cGMP and safety standards.
• Manage contract resources and act as a liaison between Engineering, Manufacturing, and Quality Assurance.
• Conduct periodic equipment reviews and perform root cause investigations using LEAN tools.
• Defend equipment calibration, maintenance, and validation during regulatory inspections and internal audits.

Required Skills

• 3+ years of relevant experience in an operations or manufacturing environment.
• Direct experience working within regulated environments such as FDA, OSHA, or EPA.
• Working knowledge of cGMP procedures and engineering practices for pharmaceutical or biotech production.
• Experience implementing risk-based verification on major GMP process equipment or automation projects.
• Proficiency in technical writing and developing SOPs or validation plans.
• Ability to perform troubleshooting and root cause analysis using Fishbone or 5-Why methods.
• Strong skills in facilitation, collaboration, and multidisciplinary team leadership.
• Availability to support activities outside regular hours as required.

Preferred Skills

• Practical application of PDCA, LEAN, or Six Sigma methodologies.
• Experience with clean utilities, facilities, instruments, and equipment.

Key Skills

Education

Any Gradaute