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 field
- OR Associate’s degree with 4 years of process engineering experience
- OR High school diploma/GED with 6 years of process engineering experience
Preferred
- Bachelor’s degree in chemical or mechanical engineering
- Pharma experience, particularly with mammalian cell culture, protein purification, clean utilities, CIP, SIP, or non-GMP utilities
- Familiarity with biopharmaceutical manufacturing equipment design and operation
- Strong written and verbal communication skills with the ability to work independently
- Demonstrated analytical skills for problem-solving and decision-making
- Proven ability to work collaboratively in cross-functional, team-based environments
Top 3 Must-Have Skills:
- Strong work ethic
- Excellent communication skills
- Bachelor’s degree in chemical or mechanical engineering, with pharma experience