Associate Process Development Engineer

Summary

Responsible for supporting the Production Services Operations Team with engineering programs, procedures, and systems that deliver products that consistently meet or exceed customer, regulatory, and company requirements. This position will support Technical Transfer activities, improve current manufacturing processes and supporting procedures; analyze and solve problems from basic engineering principles, theories and concepts through complex and advanced problems; and prepare and execute commissioning, qualification, and validations for new equipment and computerized systems/software.

• Participates in and supports Technical Transfer/Process Development projects including but not limited to:
  • Create and maintain product assembly instructions.
  • Assure 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.
  • Validate and implement new or transferred manufacturing equipment, computer system/software validations.
  • Conduct risk assessment on process steps and their ability to meet requirements.
  • Improve manufacturing efficiency by analyzing and planning workflow, space requirements, and equipment layout.
• Participates in and supports validation projects within cGMP regulated manufacturing areas including but not limited to:
  • Prepare, review, and execute commissioning, qualification and validation documents for equipment and computerized systems/software.
  • Support project teams in User Requirement Specifications, GMP Impact Assessments, Traceability Matrices, Design Qualifications, and Risk Assessments.
  • Handle multiple commissioning, qualification, and validation priorities based on the needs of the manufacturing area and project team with guidance from management.
  • Design and execute engineering (pre‑validation) studies to support validation activities.
  • Assist in troubleshooting of equipment/computer system issues, process characterization and root cause investigations.
  • Resolve deviations/non‑conformances observed during the execution of qualification and validation activities.
  • Prepare/issue change controls, CAPAs, and investigations.
  • Apply FMEA process to evaluate failure data, if necessary, from field data to find root cause and implement sound engineering solutions.

• Safely perform duties following NACS quality standards.
• Participate in team building, training and department communications.
• Work as a team player with management and co‑workers to develop a win‑win partnership through positive relationships and excellent interpersonal skills.
• Maintain a commitment to NACS’s vision and “spirit” by partnering with new and current employees by demonstrating outstanding service and integrity.
• The goal of each team member—and the team as a whole—is to create effective communications that help all employees clearly understand overall company objectives and the role they play in helping NACS meet those objectives.
• Other duties may be assigned.

Minimum of a Bachelor’s Degree in Biomedical/Mechanical Engineering or another relevant Engineering discipline. To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Ability to apply sound engineering logic to solve complex problems, assess risks, and make decisions accordingly.
• Basic understanding of ISO Quality System requirements and FDA regulations.
• Problem solver able to determine root cause of technical issues and implement effective solutions in a timely manner.
• Creative thinker with ability to think “out of the box” in a fast‑paced entrepreneurial environment.
• Resourceful and able to adapt to a variety of situations.
• Demonstrated ability to prioritize, initiate, and drive projects to completion.
• Solid knowledge of engineering fundamentals; ability to apply this knowledge to manufacturing and product design.
• Strong attention to detail.
• Must be well organized.
• Proficiency with…