Senior Validation Engineer - Packaging cGMP Lead

Socket.dev; Clinton (TN); On-site; USD 110,000 - 160,000; Full time

Job summary

Alcami is seeking a Sr. Validation Engineer in Clinton, TN to lead validation and qualification activities supporting pharmaceutical packaging operations. The role partners with engineering, quality, operations, IT, contractors, and vendors to install, qualify, and validate packaging equipment and systems.

The candidate will develop and execute validation plans, maintain documentation, and act as SME during audits, while driving continuous compliance with cGMP, data integrity, and 21 CFR Part 11.

Qualifications

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

Responsibilities

• Lead validation and qualification initiatives for packaging equipment, utilities, facilities, and computerized systems.
• Develop and execute validation protocols; maintain validation documentation.
• Manage change controls and ensure systems remain inspection-ready and compliant with cGMP, data integrity, and 21 CFR Part 11.
• Collaborate with Engineering, Quality, Operations, IT, contractors, and equipment vendors.

Skills

Analytical skills

Communication skills

Stakeholder management

Project management

Education

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

Tools

Microsoft Office

Job description

Alcami is seeking a Sr. Validation Engineer in Clinton, TN to lead validation and qualification activities supporting pharmaceutical packaging operations. The role partners with engineering, quality, operations, IT, contractors, and vendors to install, qualify, and validate packaging equipment and systems.

The candidate will develop and execute validation plans, maintain documentation, and act as SME during audits, while driving continuous compliance with cGMP, data integrity, and 21 CFR Part 11.