Senior Sterile Process Engineer — Onsite, NJ

EyeBio; Rahway (NJ); On-site; USD 117,000 - 184,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) plan

Paid holidays

Paid vacation

Job summary

EyeBio in Rahway, New Jersey, is seeking a Senior Specialist Sterile Process Engineer to lead complex formulation and sterile manufacturing activities supporting clinical drug products. You will drive tech transfers, scale-up, quality investigations, and SOP/GXP documentation while collaborating with development scientists, operations, and QA to ensure product quality and regulatory compliance.

The role is on-site in NJ, reports to the Sterile Process Engineering Lead within PSDD, and requires

Qualifications

• Bachelor's degree with minimum 5 years relevant experience; Master's with 3+ years; PhD with relevant experience.
• Strong leadership, communication, and project management capabilities.
• Experience with GMP/SOP development and quality systems.

Responsibilities

• Lead sterile process development and tech transfers for clinical drug products.
• Drive scale-up activities, investigations, and change management.
• Author GMP SOPs and GXP documents supporting sterile operations.
• Collaborate with development scientists, QA, operations, and engineering to ensure product quality.

Skills

Enterprise leadership

Interpersonal communication

Quality investigations

GMP compliance

SOP writing

Change management

Team collaboration

Problem solving

GXP documentation

Analytical thinking

Education

Bachelor's degree in Chemical Engineering/Chemistry/Pharmaceutical Sciences

Master's degree in Chemical Engineering/Chemistry/Pharmaceutical Sciences

PhD in Chemical Engineering/Chemistry/Pharmaceutical Sciences

Job description

EyeBio in Rahway, New Jersey, is seeking a Senior Specialist Sterile Process Engineer to lead complex formulation and sterile manufacturing activities supporting clinical drug products. You will drive tech transfers, scale-up, quality investigations, and SOP/GXP documentation while collaborating with development scientists, operations, and QA to ensure product quality and regulatory compliance.

The role is on-site in NJ, reports to the Sterile Process Engineering Lead within PSDD, and requires