Production Process Engineer

Guerbet; Raleigh (NC); On-site; USD 65,000 - 85,000; Full time

Job summary

Guerbet is seeking a Production Process Engineer for their Raleigh Imaging Site to support manufacturing and packaging operations. This role involves leading projects, improving processes, and ensuring adherence to FDA regulations.

The ideal candidate will possess a Bachelor's degree in Engineering and have experience in liquid formulations. Strong problem-solving, analytical, and communication skills are essential.

Guerbet is committed to diversity and inclusion, providing accommodations for applicants with disabilities.

Qualifications

• Bachelor's degree in Engineering or relevant experience.
• Experience in liquid formulation and packaging preferred.
• Familiarity with FDA, GMP, and ISO regulations.

Responsibilities

• Improve manufacturing and packaging line performance.
• Support manufacturing process per FDA guidelines.
• Lead projects and maintain safety culture.

Skills

Problem solving

Knowledge of cGMP

Analytical skills

Organizational skills

Communication skills

Attention to detail

Education

Bachelor’s degree in Engineering

Tools

Microsoft Office

Quality Management Systems (QMS)

Job description

WHAT WE ARE LOOKING FOR

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.

YOUR ROLE

• 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

YOUR BACKGROUND

REQUIRED QUALIFICATIONS

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

PREFERRED QUALIFICATIONS

• 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).

Guerbet is an Equal Opportunity Employer. As an organization, we believe that no individual should be discriminated against because of their differences, which includes the following: age, disability, ethnicity, gender, gender identity and expression, religion, or sexual orientation. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, or any other basis as protected by federal, state, or local law. Guerbet is committed to diversity, equity, and inclusion.

Guerbet provides accommodations to applicants and employees with disabilities. If you need an accommodation to apply for a position please send an email to [e-mail] or you can also call this number+19843443717