Manufacturing Process Engineer I

Abbott Laboratories • Scarborough, ME

3d • $50,700 - $101,300 • Onsite

About The Position

The Manufacturing Process Engineer I works at Abbott’s Scarborough, Maine location in the Infectious Disease, Diagnostics Division. The role is responsible for manufacturing equipment and equipment quality and cost-savings initiatives, improving efficiency through material and process improvements, reducing material processing costs, and participating in new product design. The engineer assists with development and verification of manufacturing processes and equipment, equipment start-up and validation, and technical design reviews. The position also supports quality-system effectiveness, raw-material assessment and change testing, process improvement, and the creation and maintenance of compliant technical and manufacturing documentation. The role requires compliance with applicable quality, safety, company, and regulatory requirements, including FDA requirements.

Requirements

• Bachelor’s degree in Engineering, or an equivalent combination of education and experience.
• Familiarity with cGMP and ISO 13485 regulations and practices.
• Exposure to mechanical, biomedical, industrial, or chemical engineering.
• Knowledge of engineering principles, methodologies, and industry standards.
• Demonstrated ability to manage multiple tasks, prioritize work, and maintain productivity.
• Self-motivation and ability to work productively with minimal external supervision.
• Analytical thinking and problem-solving ability.
• Verbal and written communication skills.
• Teamwork and collaboration skills.
• Technical aptitude, including interpreting technical instructions in mathematical or diagram form and working with abstract and concrete variables.
• Mathematical aptitude, including experience with concepts such as ANSI/AQL, probability, and statistics.
• Data analytics experience, including understanding data sources, compiling data, statistical analysis, and sampling plans.

Nice To Haves

• Prior experience working in a company operating under ISO, FDA, or similar quality systems or regulations.
• Exposure to cGMP and ISO 13485 regulations and practices.
• Experience with Microsoft software, such as Excel, PowerPoint, or Power BI.
• Exposure to statistical analysis software; Minitab or JMP preferred.

Responsibilities

• Carry out duties in compliance with established business policies and procedures.
• Support the development, implementation, and effectiveness of applicable quality processes in accordance with ISO, FDA, and other regulatory agency requirements.
• Exhibit professional behavior with internal and external business associates consistent with company policies and practices.
• Understand and maintain awareness of the quality consequences that may result from improper job performance.
• Support the department by performing related tasks as requested.
• Assist in designing or developing new manufacturing processes and equipment, and assist with process verification and validation.
• Conduct tests, collect and format data, and assist with analysis of engineering studies, including DOEs.
• Assist with start-up of new equipment and execution of validation protocols.
• Participate in technical design reviews for process equipment, product design, and requirements documents.
• Support quality-system effectiveness, including Quality Incident and CAPA investigations and actions.
• Analyze raw-material specifications to ensure appropriate features and limits support manufacturing processes.
• Evaluate company-initiated raw-material changes and coordinate testing and validation as required.
• Suggest and support new methods or materials for continual improvement and optimization of product or process quality and efficiency.
• Create and revise manufacturing documents, specifications, SOPs, safety instructions, validation protocols, risk assessments, and other technical documents to support compliant, efficient, and safe processes.
• Comply with FDA regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments.
• Maintain positive and cooperative communication and collaboration with employees at all levels, customers, contractors, and vendors.

Benefits

• Career development opportunities with an international company.
• Employees may qualify for free medical coverage in the Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• Retirement savings plan with a high employer contribution.
• Tuition reimbursement.
• Freedom 2 Save student debt program.
• FreeU education benefit, an affordable and convenient path to a bachelor’s degree.
• Health and wellness benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level