Job Description

Immediate need for a talented Process Engineer III (Engineering). This is a 12+ months contract opportunity with long-term potential and is located in St. Louis, MO (Remote). Please review the job description below and contact me ASAP if you are interested.

Job ID: 25-62060

Pay Range: $50 - $75/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).

Key Responsibilities:

• The successful candidate will work with a group of scientists and engineers responsible for support of commercial mammalian cell culture processes in the external manufacturing MSAT group.
• This group support commercial operations across a diverse network of manufacturing facilities and external partners.
• Key responsibilities may differ among employees with same job title and may change over time in accordance with business needs.
• Provide technical support and routine process monitoring for commercial products manufactured at CMOs.
• Provides person-in-plant observations of manufacturing operations at CMOs and communicates observations to the product team.
• Reviews manufacturing processes, deviations, and/or development and production data.
• Reviews manufacturing batch records, protocols, and control strategies.
• Provide technical support and data analysis for investigations and deviation resolution.
• Recommends changes or additional experiments to improve quality, productivity, recovery, and overall efficiency.
• Interacts with colleagues and external partners from various functions, such as Engineering, Manufacturing, and Quality departments
• Oversees and reports on overall manufacturing progress.

Key Requirements and Technology Experience:

• Key skills; Process Engineer, biologics processes, biologics development, process validation. Root cause analysis and/or risk assessment, GMP.
• Prior experience in a technical role supporting a GMP, MSAT, or commercial processes,
• Experience with equipment qualification
• Bachelor’s degree in engineering or science with 5 years of experience
• Master’s degree in engineering or science with 3 years of experience
• Experience in biologics development, bioprocess engineering, technology transfer, and / or commercial manufacturing operations
• Experience with Good Manufacturing Practices and supporting a commercial facility
• Experience in cell culture and/or downstream purification (direct lab experience a plus)
• Experience with equipment qualification and process validation
• Familiarity with formal root cause analysis and/or risk assessment
• Experience working with statistical analysis software and investigative data analysis
• Experience with project leadership
• 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 (up to 20% of time)
• Role is primarily remote, they will not report onsite daily.
• Possibility for travel to Framingham, MA and reimbursement would be provided • Possibility of extension.
• Candidates must be local to the St. Louis, MO area and willing to visit local CMO. (Location is ?5 mins from the airport)
• No other team members are local, manager sits in Framingham, MA
• Free parking onsite, coordinator with CMO
• Direct (hands-on) lab experience in biologics development would be good experience.
• Technical supporting role of commercial biologics processes.
• This would include activities like root cause investigation, process validation, lifecycle manage, and/or process trending. All of this would be done in alignment with GMP practices.
• Process validation & Root cause analysis and/or risk assessment experience
• Bachelor’s degree in engineering or science with 5 years of experience in Process Engineer 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 Nice to Have
• Prior experience in a technical role supporting a GMP, MSAT or commercial processes,
• Experience with equipment qualification

Our client is a leading Healthcare Industry, and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.

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