GMP Process Engineer & Validation Specialist

Keystone Industries; Gibbstown (NJ); On-site; USD 72,000 - 88,000; Full time

Job summary

Keystone Industries is seeking a Process Engineer in Gibbstown, NJ to develop and optimize manufacturing processes for FDA-regulated products. You will support validation activities, write CAPAs and change controls, and collaborate with QA, production, engineering, analytical, and R&D teams to ensure quality and efficient production.

Ideal candidates have 3-5 years of process engineering experience, knowledge of cGMP and ISO standards, and proficiency with validation plans and equipment

Qualifications

• 3-5 years' experience in a process engineering role involved in the manufacture of FDA-regulated products.
• Knowledge of cGMP requirements and ISO standards.
• Experience supporting process improvements, equipment implementation, validation activities, and manufacturing start-up initiatives in a regulated environment.
• Experience developing and executing validation plans and procedures.
• Knowledge of IQ/OQ/PQ protocols.
• Knowledge of process-related standards.

Responsibilities

• Develops a fundamental understanding of the processes and equipment; troubleshoot and understand the process.
• Support validation efforts for manufacturing processes, equipment, and systems, including IQ/OQ/PQ protocols.
• Write CAPAs, NCRs, process deviations, and other quality documentation for regulated production.
• Manage projects and participate in project core teams from concept through start-up.
• Interface with quality control, quality assurance, production, engineering, analytical and R&D personnel.
• Lead root cause analysis and corrective actions to reduce cost of poor quality.
• Assist in prioritizing maintenance and operational activities to maintain production schedules.

Skills

3-5 years process engineering

cGMP knowledge

problem-solving

communication

Education

BS in Chemical Engineering

Tools

AutoCAD

SolidWorks

ERP systems

Microsoft Office

D365

Job description

Keystone Industries is seeking a Process Engineer in Gibbstown, NJ to develop and optimize manufacturing processes for FDA-regulated products. You will support validation activities, write CAPAs and change controls, and collaborate with QA, production, engineering, analytical, and R&D teams to ensure quality and efficient production.

Ideal candidates have 3-5 years of process engineering experience, knowledge of cGMP and ISO standards, and proficiency with validation plans and equipment