Validation Engineer I – GMP Aseptic Processes

American Regent; New Albany (OH); On-site; USD 60,000 - 85,000; Full time

Job summary

American Regent seeks a Validation Engineer I to develop and execute validation protocols and reports supporting aseptically produced parenteral products. You will help qualify equipment, utilities and processes, maintain lifecycle documentation, and coordinate protocol approvals across Quality, Manufacturing and Engineering.

The role requires a bachelor’s degree in a life sciences or engineering field, with at least 1 year of validation experience and strong cGMP knowledge.

Qualifications

• 1+ year of validation activity experience in pharma/biopharma or life sciences.
• Familiarity with cGMP regulations and validation principles.
• Ability to read engineering drawings and design documents.
• Good technical writing and communication skills.

Responsibilities

• Develop and execute validation protocols and reports for manufacturing processes and equipment.
• Support qualification and validation of aseptic parenteral manufacturing processes and facilities.
• Maintain lifecycle documentation (UR/SF/HDS/Configuration specs).
• Review qualification/requalification packages for completeness and accuracy.
• Provide training and assist with deviation assessments and change requests.
• Coordinate protocol approvals and generate summary reports; assist in SOP development.
• Interface with Quality, Manufacturing, Packaging and Engineering to drive validation execution.

Skills

Communication

Problem solving

Planning and organization

Teamwork

Independent work

Education

Bachelor’s Degree in Life Sciences or Engineering

Tools

MS-Office

Job description

American Regent seeks a Validation Engineer I to develop and execute validation protocols and reports supporting aseptically produced parenteral products. You will help qualify equipment, utilities and processes, maintain lifecycle documentation, and coordinate protocol approvals across Quality, Manufacturing and Engineering.

The role requires a bachelor’s degree in a life sciences or engineering field, with at least 1 year of validation experience and strong cGMP knowledge.