Senior Packaging Validation Engineer - On-Site Leader

Alcami-5

Michigan

On-site

USD 120,000 - 160,000

Full time

3 days ago

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Job summary

Alcami, a trusted partner in pharmaceutical development and manufacturing, is seeking a Sr. Validation Engineer - Packaging to lead validation activities for packaging equipment, utilities, and computerized systems. You will develop protocols, manage change controls, and maintain audit-ready documentation, collaborating with Engineering, Quality, IT, and vendors.

On-site 1st shift. The role requires a Bachelor’s in engineering/chemistry/biology, 10 years in regulated manufacturing, and strong

Qualifications

10+ years of experience in a regulated manufacturing environment, preferably pharmaceutical packaging.
Experience qualifying and validating equipment, utilities, and computerized systems.
1+ year in a Pharmaceutical cGMP Manufacturing setting.
Ability to lead validation projects across cross-functional teams.

Responsibilities

Lead validation and qualification initiatives across packaging equipment, utilities, and systems.
Develop validation procedures, protocols, and MVPs.
Manage change controls and audit-ready documentation.
Provide training and SME guidance on validation practices.