Process Engineer

Description

***This is an onsite position for a Process Engineer in the Manufacturing Operations department. The

Required Education & Experience

--Bachelor's Degree (required), preferably in Engineering/Engineering Technology or a Life Science discipline.
--2-5 years of relevant work experience.
--Basic knowledge of GMP and regulatory standards.
--Strong analytical and problem-solving skills.
--Excellent communication and teamwork abilities.
--Knowledge of Lean principles and/or Six Sigma methodologies (preferred).

The Opportunity

--Focus on continuous improvement, design, automation, cGMP compliance, and quality management within manufacturing processes.
--Lead Lean Manufacturing initiatives to enhance efficiency and effectiveness.

Key Responsibilities

Process Engineering & Improvement (60%)
--Design, develop, and improve manufacturing processes for new and existing products (aiming for reduced cycle time).
--Analyze process data and perform troubleshooting to resolve technical issues and decrease downtime.
--Design and implement automation solutions to streamline processes.
--Support process validation and qualification activities.
--Utilize process simulation software and engineering tools for optimization.
--Manage project timelines for equipment repairs, maintenance, and upgrades.

Compliance & Quality (10%)
--Ensure strict adherence to current Good Manufacturing Practices (cGMP) and internal quality standards.
--Maintain documentation (flow diagrams, work instructions, reports).
--Conduct risk assessments and develop mitigation strategies.
--Assist in audit readiness and Non-Conformance Report (NCR) investigations.
--Identify and escalate potential safety hazards.

Continuous Improvement (30%)
--Apply Lean principles to eliminate inefficiencies and waste.
--Use problem-solving methodologies (e.g., Five Whys, Fishbone diagrams) for root cause analysis.
--Use statistical tools (e.g., Minitab) to analyze data and generate actionable insights.
--Establish and maintain Overall Equipment Effectiveness (OEE) improvement plans and track performance metrics.
--Develop and maintain standardized procedures and documentation.

Maintenance
--Develop and implement comprehensive preventive maintenance plans for manufacturing and test equipment.
--Coordinate with maintenance teams for scheduled maintenance, service, and calibrations.