What are the responsibilities and job description for the Senior Process Engineer position at ACE Partners?
Job Title: Process Engineer / Mechanical Engineer – Sterile Filtration SME
Location: Philadelphia, PA (On-Site)
Duration: 6 Months rolling for up to 2 Years
About the Role:
We are seeking a highly skilled Subject Matter Expert (SME) with deep expertise in Filter Validation, Extractables & Leachables studies, and Sterile Filtration.
Key Responsibilities:
- Lead and support filter validation efforts for sterile filtration processes.
- Conduct Extractables & Leachables (E&L) studies to ensure compliance and product safety.
- Provide technical expertise on filter train design for cell media preparation.
- Oversee mixing of reagents in single-use systems, ensuring process optimization.
- Collaborate with Manufacturing Science & Technology (MS&T) and Technical Operations (Tech Ops) teams to enhance process efficiency.
- Troubleshoot and resolve filtration-related process issues in a cGMP environment.
Qualifications & Experience:
- Process Engineer, Mechanical Engineer, or Manufacturing Science & Technology (MS&T) professional with relevant experience.
- Expertise in sterile filtration processes, particularly in cell media preparation.
- Hands-on experience with single-use systems and filter validation methodologies.
- Strong understanding of regulatory requirements and industry best practices for filtration and E&L studies.
- Ability to work on-site in Philadelphia, PA for the full duration of the contract.
Salary : $65 - $75
