Job Title : Process Engineer
Location : Holly Springs, NC
Contract Length : 1 Year (Possible Extension)
ONLY ABLE TO WORK WITH W2 CANDIDATES AT THIS TIME, NO C2C!
Position Summary :
We are seeking a highly motivated and detail-oriented Process Engineer to join our clients team at their North Carolina site. In this role, you will provide daily engineering support for our state-of-the-art manufacturing site. As a key member of the Process Engineering group, you will collaborate with cross-functional teams to ensure operational excellence, improve processes, and support the production of high-quality biopharmaceutical products.
Key Responsibilities :
Operational and Technical Support
- Develop, coordinate, analyze, and present results for operational issues and engineering projects.
- Provide technical support to commercial and clinical manufacturing operations with a focus on process control and equipment performance.
- Troubleshoot and resolve technical issues, ensuring minimal production downtime.
Collaboration and Communication
Work closely with manufacturing, process engineering, utility operations, quality assurance, and validation teams to implement improvements.Communicate effectively with supervisors and support staff, highlighting issues and proposing solutions.Engineering Projects and System Ownership
Complete tasks under the direction of lead engineers to meet project schedules and budgets.Own and manage assigned equipment and support operational readiness, maintenance, and improvements.Lead or support the design, development, and selection of systems, instruments, and consumables for manufacturing.Process and Technology Development
Evaluate current and potential suppliers and assess new technologies to enhance manufacturing capabilities.Advance condition-based and predictive maintenance practices using advanced data analytics.Support new product and technology introductions by performing assessments, implementing equipment modifications, and assisting with engineering runs.Compliance and Safety
Ensure systems comply with environmental health and safety regulations and GMP requirements.Perform necessary commissioning and qualification of systems and support regulatory inspections as required.Lead investigations of abnormal conditions and manage corrective / preventive actions.On-Call Support
Provide rotational on-call support, including nights, weekends, and holidays, as needed.Qualifications : Education
Bachelor’s degree in engineering or a related technical fieldOR Associate’s degree with 4 years of process engineering experienceOR High school diploma / GED with 6 years of process engineering experiencePreferred
Bachelor’s degree in chemical or mechanical engineeringPharma experience, particularly with mammalian cell culture, protein purification, clean utilities, CIP, SIP, or non-GMP utilitiesFamiliarity with biopharmaceutical manufacturing equipment design and operationStrong written and verbal communication skills with the ability to work independentlyDemonstrated analytical skills for problem-solving and decision-makingProven ability to work collaboratively in cross-functional, team-based environmentsTop 3 Must-Have Skills :
Strong work ethicExcellent communication skillsBachelor’s degree in chemical or mechanical engineering, with pharma experience
