Process Engineer Manufacturing

Primary Duties and Responsibilities

·       Responsible for the maintenance and operation of small-scale and clinical-scale equipment, including lyophilizer, milling/compounding and powder filling.

·       Provide key input in engineering design, specification, selection, and lead implementations necessary for bringing in new equipment

·       Participate in process and cycle designs/development

·       Author, review and implement of corrective actions related to equipment or process deviations

·       Use knowledge of PLC control engineering to make necessary changes in process and mechanical control

·       Properly document and communicate project progress and findings to all key stakeholders

·       Design and prepare procedures, including protocols and reports, for material and technology evaluation, as well as for process improvement and equipment qualification,

·       Perform studies in pilot plant or full production scale by following written instruction (equipment setup, data collection, sample submission, sample testing, and others)

·       Identify and qualify alternate production supplies to reduce production cost.

·       Implement major process, equipment and material changes through Change Control and Document Change Request processes, including the preparation of regulatory submission supporting documents.

·       Perform analysis using a statistical software (Minitab) to understand and interpret data, and write summary and technical reports.

·       Lead and facilitate technical problem-solving session with cross-function team through various DMAIC tools.

·       Provide technical solution to engineering team for R&D projects or continuous improvement ideas, assist validation engineer on process validation.

Job Requirements

·       Bachelor of Science in Engineering Discipline (Mechanical/Chemical/Industrial Engineering) or Biological Science, with minimum 5 to 9 years of experience in a similar engineering related field

• Knowledge of cGMP and cleanroom systems required.
• Basic knowledge of Six Sigma, DMAIC or Lean principles knowledge of equipment design and operating principals
• Hands-on experience with process tanks, continuous separators, ultrafiltration, chromatography, pumps in pilot plant or manufacturing environment
• Hands-on experience in continuous improvement project leadership
• Must be capable of working in an FDA-regulated environment
• Proficiency in Microsoft Office (Power Point, Word, Excel, Access, Visio)