Production Process Engineer

Laboratoire Guerbet•Raleigh, IL

2d•Onsite

About The Position

The Production Process Engineer operates in full compliance with applicable hygiene, safety, quality, and regulatory standards, and in alignment with the organization’s framework, company’s procedures, and the defined scope of responsibility the role is accountable for. The Production Process Engineer position is responsible for the support of the manufacturing and packaging operations within the Raleigh Imaging Site. The position will lead efforts and assist other Process Engineers in the development of study protocols, execution of studies, and development of summary reports as well as other duties as assigned to support and improve Operations. The Production Process Engineer is a "hands on" role. This position will work with little or no supervision, applying basic scientific knowledge, basic engineering knowledge, mathematics, and ingenuity to complete assignments related to the support of the manufacturing and packaging environments.

Requirements

Bachelor’s degree in an Engineering related field, Industrial, Mechanical, Electrical, etc.
Relevant experience may be substituted in lieu of degree

Nice To Haves

Experience in liquid formulation, liquid filling and packaging of syringes and vials.
Familiar with equipment control systems including vision systems
Familiar with terminal sterilization
Technical background in healthcare, nutritional products, laboratory diagnostics, medical devices, pharmaceuticals, or similar industry preferred.
Understanding of Change Management, Standard Operating Procedures, current Good Manufacturing Practices and regulatory requirements.
Familiar with Maintenance Strategy development and CMMS functionality.
Strong understanding of GMP, FDA, and ISO regulations.
Excellent analytical, organizational, and communication skills.
Strong attention to detail and ability to manage multiple priorities.
Proficient in Microsoft Office and Quality Management Systems (QMS).

Responsibilities

Improves the performance of manufacturing and packaging lines by using effective and timely problem solving, equipment improvements, and training of production and maintenance personnel as needed.
Provides support to all aspects of the manufacturing process in accordance with FDA guidelines, current Good Manufacturing Practices (cGMP), and all internal operating procedures.
Supports or Leads projects as needed.
Provides leadership to Operations to maintain a culture of collaboration, continuous improvement, safety, and strives to develop a high-performing team.
Actively participates in all Environmental, Health, and Safety aspects of the plant and ensures all safety procedures and programs are effectively being followed.
Promotes knowledge and implementation of 5S and other lean/six sigma/continuous improvement tools.
Implements measures to baseline performance and then improvement targets as they relate to cost, quality, downtime, etc.
Collect and review data using statistical tools to understand and improve processes.
Work with Manufacturing Operations Personnel and Quality Engineers to implement CAPA and change control action items.
Generate and execute change controls when necessary.
Focus on safe, efficient, reliable and repeatable operation of equipment to ensure the production of quality products.
Support site metrics to achieve and exceed KPIs.
Develops and Improves Maintenance Strategies in CMMS
Performs other duties as assigned by management