Senior Validation Engineer III: Pharma Tech Transfer

Otsuka ICU Medical LLC; Austin (TX); On-site; USD 85,000 - 120,000; Full time

Job summary

Otsuka ICU Medical LLC seeks an engineer to complete validation activities, write protocols, and assess qualification statuses under guidance. The role exposes you to advanced tasks while enabling independent and collaborative work on projects related to manufacturing equipment, facilities, and processes.

You will perform risk assessments, collect data, and communicate progress to management. Opportunities to supervise and train others are possible as you contribute to standardized documentation

Qualifications

• Bachelor’s degree from an accredited college or university is required.
• 4-7 years of validation, science/technical or engineering background required; pharmaceutical validation or engineering experience preferred.

Responsibilities

• Provide guidance and execute validation activities for manufacturing equipment, utilities, and facilities validation to support the validation and tech-transfer projects.
• Write validation plans, protocols, and reports for specific projects
• Conduct validation risk assessments related to specific projects, facilities, and products.
• Work independently to collect, organize, and evaluate validation data and keep validation management informed of progress and any obstacles.
• Largely self-directed after work is assigned. May solicit input from senior level engineers.
• Uses creative approaches in solving complex problems.
• Integrates subsystems and components in total systems design.
• Develops specifications from customer requirements.
• May supervise others during project-specific activities. Trains new/current employees with respect to documentation, use of equipment, laboratory techniques and department procedures. May provide input on performance evaluations to area manager.
• Delivers communications tailored to the needs of the receiver (managers, peers, customers) with appropriate frequency to maximize its utility and promote cross-functional collaboration.
• Brings substantive conflicts and disagreements into the open and attempts to resolve them collaboratively; builds consensus.
• Work on special projects as they arise.

Education

Bachelor’s degree

Job description

Otsuka ICU Medical LLC seeks an engineer to complete validation activities, write protocols, and assess qualification statuses under guidance. The role exposes you to advanced tasks while enabling independent and collaborative work on projects related to manufacturing equipment, facilities, and processes.

You will perform risk assessments, collect data, and communicate progress to management. Opportunities to supervise and train others are possible as you contribute to standardized documentation