Process Manufacturing Engineer

Job Title : Process Manufacturing Engineer

Location : Bridgewater, NJ

Experience : 5 7 years

Overview :

We are seeking a Process Manufacturing Engineer to shape the future of diagnostic production processes. In this role, you will define equipment specifications, lead automation initiatives, and drive projects that reduce downtime, improve yield, and ensure cGMP compliance-directly impacting product quality and operational excellence.

Key Responsibilities :

Lead the design, scale-up, and optimization of manufacturing equipment.

Plan and manage filling and packaging projects, ensuring specifications align with business and marketing goals.

Create user requirements, bid packages, and validation protocols (IQ / OQ / PQ).

Reduce equipment downtime and improve repair efficiency.

Develop SOPs, records, and specifications to support manufacturing launches.

Assess and implement process and quality improvements to drive operational excellence.

Collaborate with cross-functional teams to deliver complex projects on time.

Qualifications :

Bachelor's degree in Mechanical Engineering or a related field.

Experience in cGMP manufacturing and automated filling / packaging systems.

Knowledge of IQ / OQ / PQ validation and FDA compliance.

Background in material science, microdispensing, or injection molding is a plus.