Lead Process Engineer, Aseptic & Containment

Harba Solutions Inc.; Indiana (PA); On-site; USD 90,000 - 120,000; Full time

Job summary

A biopharmaceutical technology company is seeking a Senior Technical Expert to lead process engineering for containment systems and aseptic processing equipment. The role involves ensuring compliance in sterile manufacturing operations, leading risk assessments, and mentoring junior engineers. Candidates should possess a BS in Engineering and over 5 years of experience in regulated environments, specifically with aseptic processing and sterile technologies.

Qualifications

• 5+ years in a regulated manufacturing environment (biopharma, sterile injectables, or similar).
• Experience with aseptic processing, isolators, containment systems, or sterile manufacturing technologies.

Responsibilities

• Provide technical leadership for isolator and containment process engineering activities.
• Assess and approve process and equipment changes ensuring compliance.
• Lead risk assessments and validation activities for aseptic and containment systems.

Skills

Technical leadership

Risk assessment

Technical writing

Cross-functional leadership

Education

BS or higher in Engineering or related technical discipline

Job description

A biopharmaceutical technology company is seeking a Senior Technical Expert to lead process engineering for containment systems and aseptic processing equipment. The role involves ensuring compliance in sterile manufacturing operations, leading risk assessments, and mentoring junior engineers. Candidates should possess a BS in Engineering and over 5 years of experience in regulated environments, specifically with aseptic processing and sterile technologies.