Senior Packaging Validation Engineer

Alcami Corporation; Clinton (TN); On-site; USD 110,000 - 150,000; Full time

Job summary

The Sr. Validation Engineer - Packaging at Alcami Corporation leads qualification activities for packaging equipment, utilities, facilities, and computer systems.

You will develop protocols, maintain validation documentation, manage change controls, and ensure audit readiness under cGMP and 21 CFR Part 11. You will partner with Engineering, Quality, Operations, IT, and vendors to support installation, startup, and ongoing performance, acting as validation SME during audits and drafting SOPs and

Qualifications

• Bachelor's degree required.
• At least one year of experience in a Pharmaceutical cGMP Manufacturing setting is required.
• Minimum 10 years of experience in a regulated manufacturing environment, preferably pharmaceutical, biotech, medical device, or consumer healthcare packaging.
• Experience qualifying and validating equipment, utilities, and computerized systems within a cGMP-regulated pharmaceutical, biotech, medical device, or packaging environment.

Responsibilities

• Lead validation and qualification initiatives for packaging equipment, utilities, facilities, and computerized systems.
• Develop validation protocols, maintain documentation, and manage change controls; ensure audit readiness.
• Author and revise SOPs and Master Validation Plans (MVPs); support validation lifecycle activities.
• Partner with Engineering, Operations, Quality, IT, vendors, and contractors on qualification and validation initiatives.

Skills

Project leadership

cGMP expertise

21 CFR Part 11

Validation planning

Documentation

Education

Bachelor's degree in Engineering, Chemistry, Biology, or related field

Tools

Microsoft Office Suite

Project management tools

Job description

The Sr. Validation Engineer - Packaging at Alcami Corporation leads qualification activities for packaging equipment, utilities, facilities, and computer systems.

You will develop protocols, maintain validation documentation, manage change controls, and ensure audit readiness under cGMP and 21 CFR Part 11. You will partner with Engineering, Quality, Operations, IT, and vendors to support installation, startup, and ongoing performance, acting as validation SME during audits and drafting SOPs and