Associate Process Engineer

Ideal: B.S. in chemical or mechanical engineering. Some pharma experience in drug substance manufacturing is a plus. Looking for a go getter with some general working experience. (Does not have to be related to this position.)

What you will do

Let’s do this. Let’s change the world. In this role the Associate Engineer reports to the Senior Manager of the Process Engineering group. The position is responsible for providing daily Engineering support at the North Carolina site. Specific duties include:

• Develop, coordinate, analyze, and present results for operational issues and engineering projects

• Provide technical support to commercial and clinical manufacturing as needed, specific to process control and process equipment.

• Working closely with multiple subject areas, including manufacturing, process engineering, process development, utility operations, maintenance, quality assurance, and validation to implement operational improvements

• Communicating with supervisor and support staff, highlighting issues and proposing solutions.

• Work in a small group of engineers and/or technicians on an ongoing or project basis.

• Complete tasks under the general direction of lead engineers to complete design and engineering within schedule and budget constraints.

• Provide technical support and issue resolution with 24x7 on-call support of process systems on a rotational based frequency.

• Provide system ownership for assigned equipment, and supporting operations at the site.

• Provide engineering support for design, construction, startup, commissioning and qualification.

• Lead or work with teams in design, development and selection of new systems, instruments, calibration capabilities and consumable components.

• Evaluate capabilities of current and potential suppliers, and assess new technologies that could provide cost savings, throughput, or other unique capabilities to manufacturing.

• Identify, support, and/or lead implementation of engineering-based improvements or upgrades in small to medium scope and complexity.

• Lead the development of calibration/maintenance programs, ensure the availability of spare parts, and coordinate maintenance execution as necessary to ensure systems are in proper working order.

• Ensure systems are installed and operating safely and comply with pertinent environmental health/safety practice, rules and regulations.

• Ensure necessary commissioning and qualification of systems is completed in alignment with site GMP requirements and interact with regulatory inspectors as necessary.

• Apply basic engineering principles and practices in support of daily operation, maintenance, and troubleshooting of plant and process systems.

• Monitor systems to identify performance risks and implement risk reduction strategies.

• Providing troubleshooting support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive action. (Support may be required outside of normal working hours including nights, weekends and holidays)

• Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs.

• Advance the use of condition based and predictive maintenance practices by incorporating advanced data analytics where applicable.

• Own investigations of abnormal conditions through Deviation and business processes.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The engineering professional we seek is a dynamic, flexible, and driven individual with these qualifications.

Basic Qualifications:

• Bachelor’s degree

Or

• Associate’s degree and 4 years of Process Engineer experience

Or

• High school diploma / GED and 6 years of Process Engineer experience

• Ability to provide On-Call support coverage nights and weekends, on a rotating basis.

Preferred Qualifications:

• Bachelor’s degree in engineering or related technical field

• Position requires strong written and verbal skills and the ability to work with minimum direction.

• Demonstrated interpersonal and facilitation skills and ability to work in a collaborative team-based environment.

• Ability to apply analytical skills to evaluate and interpret sophisticated problems using multiple sources of information.

• Ability to function within cross-functional teams and embrace a team-based environment.

• Experience with Mammalian Cell Culture, Protein Purification, Clean Utilities, CIP, SIP, Production Services, and/or non-GMP Utilities preferred

• Familiarity with designing and operating equipment used in biopharmaceutical manufacturing preferred

Pay Rate: $28-31/Hr *Salary will be commensurate with candidate experience