Senior Validation Engineer - Pharma Packaging & Compliance

ADP, Inc.; Clinton (TN); On-site; USD 90,000 - 140,000; Full time

Job summary

Alcami is a contract development and manufacturing organization seeking a Senior Validation Engineer in Clinton, TN to lead validation across packaging equipment, utilities, facilities, and computerized systems.

The role develops protocols, maintains validation documentation, manages change controls, and ensures audit-ready systems compliant with cGMP, data integrity, and 21 CFR Part 11. Collaboration with engineering, quality, operations, IT, and vendors is essential.

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 packaging.
• Experience qualifying and validating equipment, utilities, and computerized systems within cGMP environments.
• Ability to lead validation projects, manage change controls, and maintain validated states.

Responsibilities

• Lead validation and qualification initiatives for packaging equipment, utilities, facilities, and computerized systems.
• Develop protocols, maintain validation documentation, and manage change controls.
• Serve as SME during audits and provide technical guidance on validation practices.
• Author SOPs and Master Validation Plans and support training programs.
• Collaborate with Engineering, Quality, IT, operations, and external vendors.

Skills

Validation

Qualification

Documentation

Audit readiness

Cross-functional teamwork

Education

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

Tools

Microsoft Office Suite

Job description

Alcami is a contract development and manufacturing organization seeking a Senior Validation Engineer in Clinton, TN to lead validation across packaging equipment, utilities, facilities, and computerized systems.

The role develops protocols, maintains validation documentation, manages change controls, and ensures audit-ready systems compliant with cGMP, data integrity, and 21 CFR Part 11. Collaboration with engineering, quality, operations, IT, and vendors is essential.