What are the responsibilities and job description for the Process Engineer position at I3 INFOTEK INC?
Title: Process Engineer
Location: St. Louis, Missouri area (Role is primarily remote, but must be able to travel to visit local CMO's as required)
Duration: 12 (Possibility of extension)
Note: Open to candidates who are willing to relocate to the area at their own expense.
Possibility for travel to Framingham, MA and reimbursement would be provided.
REQUIREMENTS:
- Strong Process validation experience
- CMO oversight experience a BIG PLUS
- Direct (hands-on) LAB experience in biologics
- Cell Culture and/or purification experience
- Root cause analysis and/or risk assessment
- Experience in biologics development, bioprocess engineering, technology transfer, and / or commercial manufacturing operations
- Technical supporting role of commercial biologics processes. This would include activities like root cause investigation, process validation, lifecycle management, and/or process trending. All of this would be done in alignment with GMP practices.
- Bachelor’s degree in engineering or science with 5 years of experience in Process Engineering or related role at Pharm/ Biotech Company OR Master’s degree in engineering or science with 3 years’ experience in Process Engineer or related role at Pharm/ Biotech Company
- PhD candidates welcome if min of 3 years of experience as mentioned above
- Experience with Good Manufacturing Practices and supporting a commercial facility
- Experience communicating with cross functional teams
- Strong technical writing and communication skills
- Proficient in Microsoft Word, Excel, and PowerPoint
- Ability to gown and gain entry to manufacturing areas
- Ability to travel to CMO's (up to 20% of time)
