Associate Process Development Engineer

About the role

Responsible for supporting the Production Services Operations Team with engineering programs, procedures, and systems that deliver products consistently meeting or exceeding customer, regulatory, and company requirements. This position supports Technical Transfer activities, improves current manufacturing processes and supporting procedures, analyzes and solves problems from basic engineering principles through complex issues, and prepares and executes commissioning, qualification, and validations for new equipment and computerized systems/software.

Responsibilities

• Participates in and supports Technical Transfer/Process Development projects, including:
  • Creating and maintaining product assembly instructions.
  • Assuring product and process quality by designing testing methods, testing finished goods, determining product and process capabilities, establishing standards, and confirming manufacturing processes with guidance from management.
  • Validation and implementation of new or transferred manufacturing equipment and computer system/software validations.
  • Conducting risk assessments on process steps and their ability to meet requirements.
  • Improving manufacturing efficiency by analyzing and planning workflow, space requirements, and equipment layout.
• Participates in and supports validation projects within cGMP-regulated manufacturing areas, including:
  • Preparing, reviewing, and executing commissioning, qualification, and validation documents for equipment and computerized systems/software.
  • Supporting project teams with User Requirement Specifications, GMP Impact Assessments, Traceability Matrices, Design Qualifications, and Risk Assessments.
  • Handling multiple commissioning, qualification, and validation priorities based on manufacturing and project team needs.
  • Designing and executing engineering (pre-validation) studies to support validation activities.
  • Assisting in troubleshooting equipment/computer system issues, process characterization, and root cause investigations.
  • Resolving deviations/non-conformances observed during qualification and validation activities.
  • Preparing/issuing change controls, CAPAs, and investigations.
  • Applying FMEA process to evaluate failure data and implement engineering solutions.
• Safely performs duties following NACS quality standards.
• Participates in team building, training, and department communications.
• Works collaboratively with management and co-workers to develop positive relationships and partnerships.
• Maintains commitment to NACS’s vision and values by demonstrating service and integrity.
• Other duties as assigned.

Requirements

• Minimum of a Bachelor’s Degree in Biomedical/Mechanical Engineering or other relevant Engineering discipline.
• Ability to apply sound engineering logic to solve complex problems, assess risks, and make decisions.
• Basic understanding of ISO Quality System requirements and FDA regulations.
• Problem-solving skills to determine root causes of technical issues and implement timely solutions.
• Creative thinker with the ability to adapt in a fast-paced entrepreneurial environment.
• Resourcefulness and adaptability to a variety of situations.
• Demonstrated ability to prioritize, initiate, and drive projects to completion.
• Solid knowledge of engineering fundamentals and their application to manufacturing and product development.
• Strong attention to detail and organizational skills.
• Proficiency with MS Office (Word, Excel).
• Good written and verbal communication skills.

Qualifications

Bachelor’s Degree in Biomedical/Mechanical Engineering or other relevant Engineering discipline, preferably with 1–3 years of relevant experience, or 5–7 years of experience without a university degree.

Experience in Equipment Qualification and Computer System/Software Validation preferred.

Ability to read, analyze, and interpret complex documentation, and write complex documentation.

Effective communication skills at all levels within the company.

Knowledge and application of mathematics, trigonometry, algebra, and statistics.

Physical Demands

• Regularly required to stand, sit, talk, walk, use hands, see, and hear.
• Occasional travel to customer sites for meetings.
• Infrequent lifting of up to 25 pounds.

Work Environment

The work environment is generally clean with moderate noise levels. Air quality is typically clean, with occasional welding smoke or cleaning solvent smells. The production environment includes an ISO class 7 or 8 cleanroom.