User Rep - Process Engineer Synthesis
- North America, United States
- Contract
- CAPEX Projects
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.
- 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.
#LI-AN1
We have worked together with QCS Staffing for seven years now and have always received a professional service. QCS Staffing's speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of QCS Staffing's people and their ability to deliver.
Global Pharmaceutical firm
I have always received a highly professional & personable service from the team at QCS Staffing. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
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