Senior Process Development Engineer Job Description Template
Our company is looking for a Senior Process Development Engineer to join our team.
Responsibilities:
- Lead and/or support prototype projects where novel processing is required;
- Participate in material review board meetings and support production scrap reduction activities;
- Serve as liaison between sales, engineering, and manufacturing to ensure the orderly flow of information and materials;
- Recommend equipment improvements and upgrades to enhance safety, reliability and capability;
- Maintaining a clean work environment;
- Develop and conduct process training programs, demonstrating skills to trainees;
- Support and drive 6S programs and practices to maintain a safe working environment with good housekeeping practices;
- Design and development of internal scalable fermentation processes for a variety of anaerobic microbial strains;
- Authoring CMC sections of briefing books and/or other submissions (e.g. IND) for regulatory authorities;
- Ordering and inventorying raw materials;
- Identifying and qualifying analytical methods in order to ensure the delivery of quality products for dosing;
- Communicate clearly, work independently, collaborate heavily, think critically;
- Preparing media, buffers, single-use components for GMP use;
- Setting appropriate release specifications for the components of the drug substance as well as the final drug product;
- Coordinating 3rd party contractors and vendors as needed.
Requirements:
- Ability to use standard software such as Word, Excel, Outlook, Minitab, CAD;
- Travel as required to remote plants, facilities, customers or suppliers;
- Exceptional organizational skills and documentation skills;
- Must be able to handle multiple projects at any given time and prioritize efforts as needed;
- Knowledge of printed electronics manufacturing processes: functional printing, converting, stamping, plating and assembly;
- Willingness to work occasional overtime and weekends as needed to support project execution.