Validation Engineer 1

Job Responsibilities

• Support the project team and/or General Contractor, as needed, in commissioning and validation activities for GMP and supporting spaces.
• Aid 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.
• Execute or support equipment, utility, and process qualification activities as required.
• Assist with 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.

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.

Skills And 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.

Physical Demands

• Sit, reach with hands and arms, and talk or hear.
• Lift and/or move up to 30 pounds occasionally.