After having met several important milestones including exciting clinical data, we are poised for new strategic objectives which will require significant new resources. Those new resources include a well-qualified Process Engineer.
Process engineering support for barrier isolator, automated fill and finish equipment, and custom automated equipment development and management for clinical and commercial manufacturing. Also provides engineering support for the design and development of ancillary equipment required for semi-automated manufacturing.
- Process Engineering – Evaluate equipment design and build options during development to ensure robust solutions meeting process requirements are specified. Ensure user requirements are defined and met. Work collaboratively with consulting engineers, development firms, and equipment vendors to support equipment design and build efforts. This includes supporting mock-ups, FATs and SATs. Manage design projects for ancillary equipment supporting semi-automated manufacturing. Solve tasks independently at variable levels of complexity. Work collaboratively with relevant project managers to maintain vendor schedules to meet corporate goals and objectives. Support clinical and commercial manufacturing efforts and continuous improvement on processes and equipment. Maintain reliable and safe manufacturing systems while improving production rates, efficiencies, yields, costs, and changeovers.
- Validation – Work collaboratively with Validation personnel as a subject matter expert to generate and review documents required to support validation efforts. Support validation protocol execution.
- MS&T – Evaluate proposed changes to assess impact to process and equipment. Providing technical assessments for process equipment-related investigations.
- Confidentiality – Ensure that information and documentation pertaining to Argos Therapeutics, Inc. is treated as confidential information and handled appropriately as confidential information.
- Safety – Perform all job functions and responsibilities in a safe and responsible manner. Ensure compliance of co-workers with all safety policies and procedures at all times.
- Other duties as required.
- Requires a BS degree in chemical or mechanical engineering with 5+ years related experience or a MS degree in chemical or mechanical engineering with 3+ years related experience
- Experience with filling and isolator systems utilizing high speed, robotic, and fully automated systems is required.
- Experience with equipment documentation creation and review, such as but not limited to, FAT/SAT, ETOP, CQV, PV, etc., is required.
- Experience with leading and managing multi-disciplinary cross functional teams focusing on installation, qualification, and troubleshooting/optimization of process systems is required.
- Good interpersonal and communication skills are required.
- Excellent decision making and creative problem solving skills.
- Flexibility on work schedules and duties.
We offer a competitive compensation package along with outstanding benefits. For confidential consideration, please submit a resume with a cover letter and salary history.
No phone calls please.
Argos Therapeutics is an Equal Opportunity Employer.