Senior Validation Engineer
$107,904–$130,754 year
On-siteIndianapolis, Indiana, United States
Job Summary
Draft and execute commissioning, qualification, and validation (CQV) documents and protocols for radiopharmaceutical facility, utility, analytical, and process equipment. Support the engineering, QC, and Operations teams to improve new processes, manage deviation investigations, and oversee CAPA management. Own specific validation areas such as process validation, QC assets, CSV, and cleaning validation while drafting GMP documentation including SOPs, protocols, and technical reports. Work with project teams and consultants to validate a 60,000 sq. ft. GMP production facility, execute equipment and process validations, and maintain department KPIs. Maintain Health Authority inspection readiness and mentor team members in a GMP cleanroom environment handling radioactive materials.
Required Qualifications
- BS or MS in scientific related field
- 4-8 years of experience in Radiopharmaceutical or injectable GMP manufacturing environment
- 4-8 years of validation experience within a GMP environment
- Good technical writing skill-set
- Solid understanding of regulatory guidelines for validation and risk management
- Must possess an independent mindset and tenacity
- Highly motivated and organized professional with strong interpersonal and communication skills
- Proven experience working with teams in a GMP environment
- Multi disciplined engineer with GMP experience
- Excellent professional ethics, integrity, and ability to maintain confidential information
- Uses AI tools to enhance individual productivity and quality of work
- Specific vision abilities required by this job include close vision and distance vision
- This is a position that requires working in a GMP cleanroom environment, wearing protective clothing, and handling of radioactive materials
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