Validation Engineer 1

About the role

The Validation Engineer I supports the Radiopharmaceutical facility and GMP operations in Indianapolis. This role assists with the drafting and execution of commissioning, qualification, and validation (CQV) documents and protocols that support specialized facility, utility, analytical, and process equipment.

Responsibilities

• Support the project team and/or General Contractor, as needed, in commissioning and validation activities for GMP and supporting spaces.
• Assist in the development and implementation of CQV strategies for office, warehouse, development, quality control, sterility/microbiology, and GMP production areas.
• Partner with consultants and cross-functional teams to support the implementation and execution of the CQV program.
• Provide validation support for day-to-day development and GMP operations.
• Execute or support equipment, utility, and process qualification activities as required.
• Aid in drafting GMP documentation including SOPs, forms, protocols, technical documents, reports, deviations, CAPAs, and change controls.
• Review data and documentation to support investigations and validation packages.
• Contribute to continuous improvement projects and assigned validation initiatives.
• Build knowledge in additional areas of validation such as process validation, QC assets, computer system validation, and cleaning validation.
• Support department KPI tracking and inspection readiness activities.
• Provide engineering and operational support as needed.

Requirements

Education and Experience:

• Bachelor’s degree in engineering, life sciences, or a related scientific field, or equivalent work experience.
• 0-2 years of experience in a GMP manufacturing environment, preferably in radiopharmaceutical or injectable manufacturing.
• Exposure to validation, commissioning, qualification, or related technical support activities is preferred.

Qualifications

• Basic technical writing skills.
• Foundational understanding of validation principles, GMP requirements, and risk management concepts.
• Strong attention to detail, organization, and willingness to learn.
• Effective interpersonal and communication skills.
• Ability to work collaboratively in a cross-functional GMP environment.
• Demonstrated professionalism, integrity, and ability to handle confidential information appropriately.
• Problem-solving mindset with the ability to follow direction and grow into increased technical ownership.
• Use AI tools to enhance individual productivity and quality of work.

Skills

• Basic technical writing skills.
• Foundational understanding of validation principles, GMP requirements, and risk management concepts.
• Strong attention to detail, organization, and willingness to learn.
• Effective interpersonal and communication skills.
• Ability to work collaboratively in a cross-functional GMP environment.
• Demonstrated professionalism, integrity, and ability to handle confidential information appropriately.
• Problem-solving mindset with the ability to follow direction and grow into increased technical ownership.
• Use AI tools to enhance individual productivity and quality of work.