Process Engineer – Synthesis
- North America, United States
- Contract
- CAPEX Projects
This is a fantastic opportunity for a 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 guidance and technical support to front-line process engineers to enhance their skill sets and process understanding.
- Assist in knowledge transfer by developing and delivering training programs.
- Foster a culture of technical excellence and continuous improvement within the team.
- Develop, document, and sustain comprehensive process knowledge related to synthesis of API molecules within GMP environments.
- Identify and implement process improvements to enhance efficiency, product quality, and compliance.
- Collaborate with quality, operations, and engineering teams to troubleshoot and resolve process challenges.
- Provide technical expertise in the design, operation, and troubleshooting of synthesis processes and associated equipment.
- Support the commissioning and qualification (C&Q) phases for process equipment and ensure compliance with GMP guidelines.
- Work closely with maintenance teams to optimize equipment performance and reliability.
- Maintain accurate engineering documentation, including process descriptions, SOPs, and validation protocols.
- Support the implementation and maintenance of asset management programs to maximize operational uptime and efficiency.
- Contribute to change management processes and ensure compliance with regulatory standards.
- Bachelor's or Master’s degree in Process Engineering, Chemical Engineering, or a related field.
- Extensive experience in API manufacturing unit operations or similar process-driven environments.
- Strong understanding of GMP requirements and experience supporting regulatory compliance in pharmaceutical or biotech industries.
- Hands-on experience with process optimization, troubleshooting, and scaling-up synthesis operations.
- Ability to work collaboratively across departments and effectively communicate technical concepts.
- Experience in peptide or small molecule synthesis in GMP facilities.
- Familiarity with automation systems and process control strategies.
- Knowledge of Lean Six Sigma or other continuous improvement methodologies.
- Strong analytical and problem-solving skills with the ability to manage multiple priorities.
#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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