Process Engineer III (Engineering)

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 - $75hour. 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, andor 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 teracts with colleagues and external partners from various functions, such as Engineering, Manufacturing, and Quality departmentsOversees and reports on overall manufacturing progress.Key Requirements and Technology Experience: Key skills; Process Engineer, biologics processes, biologics development, process validation. Root cause analysis andor risk assessment, GMP.Prior experience in a technical role supporting a GMP, MSAT, or commercial processes, Experience with equipment qualificationBachelor's degree in engineering or science with 5 years of experienceMaster's degree in engineering or science with 3 years of experienceExperience in biologics development, bioprocess engineering, technology transfer, and or commercial manufacturing operationsExperience with Good Manufacturing Practices and supporting a commercial facilityExperience in cell culture andor downstream purification (direct lab experience a plus)Experience with equipment qualification and process validationFamiliarity with formal root cause analysis andor risk assessmentExperience working with statistical analysis software and investigative data analysisExperience with project leadershipExperience communicating with cross functional teamsStrong technical writing and communication skillsProficient in Microsoft Word, Excel, and PowerPointAbility to gown and gain entry to manufacturing areasAbility 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, MAFree parking onsite, coordinator with CMODirect (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, andor process trending. All of this would be done in alignment with GMP practices.Process validation & Root cause analysis andor risk assessment experienceBachelor'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 CompanyPhD candidates welcome if min of 3 years of experience as mentioned above Nice to HavePrior experience in a technical role supporting a GMP, MSAT or commercial processes,Experience with equipment qualificationOur 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.Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.By applying to our jobs you agree to receive calls, AI-generated calls, text messages, or emails from Pyramid Consulting, Inc. and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here.

Created: 2025-03-07