Senior Packaging Validation Engineer - On-Site Leader

Alcami; Michigan; On-site; USD 120,000 - 160,000; Full time

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.

Skills

Lead validation projects

Analytical skills

Communication & stakeholder mgmt

Microsoft Office Suite

Project management tools

Education

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

Tools

Microsoft Project

Job description

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