What are the responsibilities and job description for the Senior Sterilization Engineer position at ACE Partners?
Sr. Associate, Sterilization Engineering
Location: Scottsdale, AZ | Hybrid (3 days on-site / 2 days remote) | Relocation assistance available
Department: R&D
Travel: 10%
We're looking for a Sterilization Engineering subject matter expert to lead sterilization workstreams for injectable drug delivery products. You'll drive technical decisions, partner with cross-functional teams, and ensure processes are compliant and commercially viable from concept through launch.
Responsibilities
- Develop and execute sterilization strategies for medical devices
- Conduct risk assessments and validation studies
- Ensure compliance with industry standards and regulatory requirements
- Collaborate with R&D, Quality, and operations on product introductions and transfers
- Investigate and resolve equipment and process issues
- Manage regulatory filings and support audits
- Train and mentor R&D team members
- Identify process improvement and cost-reduction opportunities
Qualifications
- Bachelor's in Microbiology, Biomedical Engineering, Chemical Engineering, or related field (Master's preferred)
- 5 years in sterilization, medical device, or pharmaceutical development
- Experience with CAPAs, deviations, non-conformances, and complaint handling
- Background in QMS within a regulated environment
- Strong communication and problem-solving skills
Salary : $110,000 - $122,000