Summary of Role
- Follows good manufacturing practices (GMP) and principles to develop robust manufacturing processes. Has a primary role in the engineering and validation of new products in the Biopharmaceutical assembly space but is also the subject matter expert for existing manufacturing operations in a clean-room environment.
Tasks and Responsibilities
- Analyzes new product specifications and translates these into manufacturing processes to establish production rates, achieve expected quality levels and establish reliability of finished product.
- Conducts reviews of new and revised mold tooling.
- Acts as mold design review input champion.
- Develops and optimizes polymer conversion process parameters for new tools.
- Develops decoupled molding parameters to ensure process control.
- Develops process parameters for secondary operations, including ultrasonic welding, bonding, and testing.
- Conducts data analysis and collaboration with Project Engineering and Quality Engineering.
- Perform Installation Qualifications (IQ) and Equipment Qualifications (EQ), as necessary.
- Identifies Operational Qualification (OQ) process parameters and Performance Qualification (PQ) settings.
- Develops and documents standard operating procedures (SOP) and product-specific operating procedures (PSOP).
- Trains manufacturing personnel on SOPs and PSOPs.
- Performs DOEs, and participates in the development of control plans, Process Maps, and PFMEA documentation.
- Organizes internal cross-functional teams and corresponding outside vendors needed to meet project needs. Procures equipment as needed.
- Uses standard problem solving tools, e.g., 8D, 5 Whys, Fishbone.
- Applies effective inter-departmental communication and escalation.
- Owns tooling and process from a manufacturability standpoint from development to production release.
- Partners with Quality department on investigation and corrective action for any failed First Article Inspection or OQ/PQ.
Senior Process Engineer:
- Provide mentorship to Process Engineers and Technicians
- Autonomously directs team members to lead projects through to successful completion.
- Provides mentorship to other Process Engineers and Technicians through experiences and education as opportunities arise
- Develops ideas and strategies to improve operational efficiency, add value, aid business performance and work towards a culture of continuous improvement
- Successfully manages multiple high-profile projects simultaneously
Education and Experience
- 4 year degree in Industrial, Manufacturing, Plastics or Mechanical Engineering or a related discipline
- 3-7 years of Biopharmaceutical processing or component manufacturing
- Senior Process Engineer:
- 4 year degree in Industrial, Manufacturing, Plastics or Mechanical Engineering or related discipline
- Lean Sigma Green or Black Belt certification
- 7 years of experience in manufacturing engineering or related discipline
- 7+ years of Biopharmaceutical processing or component manufacturing
- Ability to read, write, speak and understand the English language
- Ability to communicate clearly by conveying and receiving ideas, information and direction effectively
- Ability to demonstrate adequate job knowledge to deliver a world class performance
- Ability to challenge oneself to consistently meet all goals and deadlines
- Willingness to strive for excellence by producing work that is free of errors and mistakes
- Desire to delight both customers and coworkers by offering encouragement, fostering teamwork and addressing conflict appropriately
- Commitment to making improvements company wide
- Demonstrated competence using Microsoft Office
- Use of statistical analysis software
- Interpersonal skills and good communication technique
- Ability to coordinate multiple projects and deadlines, manage and identify scope
- Act as a project leader on major projects
- Lean Manufacturing- Proficient in use of problem solving tools such as 5 why, Fishbone, 8D, etc.
- Understanding of manufacturing processes for medical components and devices.
- Good understanding of metrology principles and methods.
Last Application Date is 06/01/2023
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