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User Rep - Process Engineer Synthesis

  1. North America, United States
Ohio
  1. Contract
Competitive
  1. CAPEX Projects
36192

This vacancy has now expired

User Rep, Process Engineer Synthesis - Ohio - 12 Months Contract with planned extensions 

This is a fantastic opportunity for a User Rep - Process Engineer Synthesis to join our major, global pharmaceutical client on their latest new-build project based in Ohio, this is a large-scale greenfield capital project and investing more than $1bn.

Responsibilities:
  • Provide hands-on guidance and technical mentorship to junior and front-line process engineers.
  • Develop and implement training programs to enhance process knowledge and best practices.
  • Foster a culture of collaboration and technical excellence within the team.
  • Develop and maintain in-depth process knowledge of purification operations, including chromatography, ultra-filtration/diafiltration (UF/DF), and filtration techniques.
  • Identify opportunities to enhance purification process efficiency, product yield, and quality.
  • Collaborate with cross-functional teams to troubleshoot purification process challenges and ensure continuous improvement.
  • Support process engineering efforts related to the design, commissioning, and qualification of purification equipment.
  • Provide technical expertise in equipment selection, installation, validation, and troubleshooting to ensure optimal performance.
  • Ensure purification systems are maintained in compliance with GMP and regulatory requirements.
  • Develop and maintain engineering documentation, including process flow diagrams (PFDs), standard operating procedures (SOPs), and technical reports.
  • Lead efforts in asset life-cycle management and performance optimization of purification equipment.
  • Participate in change management processes and ensure compliance with corporate and regulatory standards.
Skills and Experience:
  • Bachelor's or Master’s degree in Process Engineering, Chemical Engineering, or a related field.
  • Extensive relevant experience in API manufacturing purification operations or similar environments.
  • In-depth knowledge of chromatography, filtration (including depth and sterile filtration), and ultra-filtration/diafiltration (UF/DF) processes.
  • Experience supporting regulatory compliance, equipment qualification, and process validation.
  • Strong problem-solving skills and the ability to work effectively across multidisciplinary teams.
  • Experience with single-use purification systems and continuous manufacturing technologies.
  • Proficiency in process automation systems and data integrity requirements.
  • Knowledge of Lean Six Sigma or continuous improvement methodologies.
  • Excellent communication and leadership skills to drive team development and project success.
If this role is of interest, please apply now!
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