Senior Validation Engineer - Packaging & Compliance

Tjoapack; Michigan; On-site; USD 110,000 - 160,000; Full time

Job summary

Alcami is a contract development and manufacturing organization with decades of experience, seeking a Senior Validation Engineer to lead qualification activities across packaging, utilities, and systems. You will author validation plans, coordinate cross-functional teams, and ensure audit-ready documentation.

The role requires a strong background in pharmaceutical cGMP environments, with ability to manage change controls and mentor peers while driving continuous compliance in a fast-paced

Qualifications

• Bachelor's degree in Engineering, Chemistry, Biology, or related field is 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 packaging.
• Experience qualifying and validating equipment, utilities, and computerized systems within a cGMP-regulated pharmaceutical, biotech, medical device, or packaging environment.
• Proven ability to lead validation projects, support new equipment implementation, manage change controls, and maintain systems in a validated state throughout their lifecycle.

Responsibilities

• Lead validation and qualification activities for packaging operations.
• Develop and execute validation protocols; maintain validation documentation.
• Manage change controls and periodic system reviews.
• Serve as validation SME during audits and provide training.
• Collaborate with Engineering, Quality, IT, and external vendors.

Skills

Analytical thinking

Communication skills

Stakeholder management

Cross-functional collaboration

Technical leadership

Education

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

Tools

Microsoft Office

Job description

Alcami is a contract development and manufacturing organization with decades of experience, seeking a Senior Validation Engineer to lead qualification activities across packaging, utilities, and systems. You will author validation plans, coordinate cross-functional teams, and ensure audit-ready documentation.

The role requires a strong background in pharmaceutical cGMP environments, with ability to manage change controls and mentor peers while driving continuous compliance in a fast-paced