Pharma Validation Engineer I - Aseptic Manufacturing

americanregent; New Albany (OH); On-site; USD 65,000 - 95,000; Full time

Job summary

American Regent is seeking a Validation Engineer I to develop and execute validation protocols and reports supporting GMP-compliant pharmaceutical manufacturing.

The role involves acting as SME for packaging, equipment, and cleaning validation, supporting installation, operation, and performance qualification of equipment and processes used in aseptic parenteral production. Strong documentation and communication skills are essential.

Qualifications

• Bachelor's degree in Life Sciences or Engineering required.
• Minimum 1 year validating pharmaceutical/life sciences processes.
• Strong knowledge of cGMP and validation principles.
• Good technical writing and communication skills.
• Ability to work independently and as part of a team.

Responsibilities

• Develop and execute validation protocols and reports for manufacturing processes.
• Validate aseptic manufacturing processes, including lyophilized and solution forms.
• Review and approve qualification/requalification packages for accuracy and compliance.
• Provide technical input for deviations and change requests.
• Coordinate protocol approvals and lifecycle documentation.

Skills

Validation expertise

GMP knowledge

Technical writing

MS Office

Education

Bachelor's degree in Life Sciences or Engineering

Tools

MS Excel

Documentation tools

Job description

American Regent is seeking a Validation Engineer I to develop and execute validation protocols and reports supporting GMP-compliant pharmaceutical manufacturing.

The role involves acting as SME for packaging, equipment, and cleaning validation, supporting installation, operation, and performance qualification of equipment and processes used in aseptic parenteral production. Strong documentation and communication skills are essential.