PE Global is recruiting for a Process Engineer for a leading multi-national Biologics client.
This is an initial 11-month contract position requiring technical and operations expertise.
Key Responsibilities
* Serve as technical representative for established manufacturing processes and new product introduction.
* Collaborate with cross-functional teams to perform vendor management, communications, training, project work, audit/inspection duties, and ensure department readiness.
* Design, author, review, approve, and execute process updates in support of ongoing manufacturing support and new product introduction.
* Provide technical input into quality notifications by authoring, reviewing, and approving investigations.
* Drive continuous process improvements using Lean Principles to optimize equipment uptime and target outputs.
* Oversee operations processes to ensure continuous, reliable, and repeatable manufacturing.
* Develop and implement accurate operational procedures, training materials, and manufacturing procedures.
* Ensure process reliability and performance by identifying root cause failures, making recommendations, and implementing improvement changes.
* Lead and participate in system failure investigations, investigation reports, change control execution, and Kaizen events.
* Support equipment commissioning and qualification programs representing operations.
* Review and approve qualification/validation documentation and studies.
* Analyze data and make informed decisions/recommendations based on the analysis.
* Support continuous improvement through Lean Six Sigma methodologies.
* Participate and lead cross-functional or single function teams, including liaison with vendors or above site groups.
* Comply with company policies, procedures, guidelines, regulatory requirements, and current Good Manufacturing Practices (cGMP).
Requirements
* Bachelor's Degree or equivalent in Science, Engineering, or Technical discipline.
* Established experience in a process engineer role with measurable accomplishments and achievements.
* Relevant experience and skill set in their area of expertise adding value to the business; ideally in a GMP setting.