Senior Sterile Process Engineer - Scale-Up & CAPA Leader

Socket.dev; Piscataway Township (NJ); On-site; USD 100,000 - 120,000; Full time

Benefits offered by this job

401(k) matching

Comprehensive benefits

Career growth opportunities

Job summary

Amneal in New Jersey is seeking a Senior Process Engineer to drive sterile manufacturing transfers from concept to launch, including scaling up and aseptic process simulation. This role collaborates with R&D and Manufacturing teams to ensure seamless transition to full-scale commercial production.

The ideal candidate has 5+ years in GMP life-sciences manufacturing and a track record of leading investigations and CAPA programs, with a focus on filling, packaging, lyophilization, and

Qualifications

• Strong understanding of cGMP, FDA regulations and relevant standards.
• Proven project management and leadership skills.
• Exceptional problem-solving and decision-making abilities.
• Strong communication and interpersonal skills across teams.
• Proficiency in relevant engineering software and tools.

Responsibilities

• Develop, author and execute protocols to ensure FDA and cGMP compliance, including validation and qualification.
• Plan technical strategies, scopes, studies, schedules to establish process capability and support product introductions.
• Provide real-time troubleshooting for equipment and process deviations; train personnel and support start-ups.
• Act as SME for sterile/aseptic processes, including formulation, filling, packaging, lyophilization, and root cause analysis.

Skills

cGMP knowledge

Project management

Problem solving

Communication skills

Engineering software

Education

Bachelor's degree in Engineering or related field

Master's degree in Engineering or related field

Tools

Job description

Amneal in New Jersey is seeking a Senior Process Engineer to drive sterile manufacturing transfers from concept to launch, including scaling up and aseptic process simulation. This role collaborates with R&D and Manufacturing teams to ensure seamless transition to full-scale commercial production.

The ideal candidate has 5+ years in GMP life-sciences manufacturing and a track record of leading investigations and CAPA programs, with a focus on filling, packaging, lyophilization, and