Associate Process Engineer, (JP13534)

3 Key Consulting • Holly Springs, NC

5d • Onsite

About The Position

3 Key Consulting is hiring an Associate Process Engineer for a consulting engagement with their direct client, a leading global biotechnology company. The ideal candidate will have a B.S. degree in chemical or mechanical engineering, with some pharma experience in drug substance manufacturing being a plus. This role is for a motivated individual with general working experience, not necessarily related to this specific position.

Requirements

• Strong working ethics
• Strong communication
• B.S. in chemical or mechanical engineering
• Pharma experience
• 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.

Nice To Haves

• Some pharma experience in drug substance manufacturing
• General working experience (does not have to be related to this position)
• Bachelor’s degree in engineering or related technical field
• 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
• Familiarity with designing and operating equipment used in biopharmaceutical manufacturing

Responsibilities

• 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.
• Work closely with multiple subject areas, including manufacturing, process engineering, process development, utility operations, maintenance, quality assurance, and validation to implement operational improvements.
• Communicate 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 support 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 client 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.
• Provide troubleshooting support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive action.
• 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.

Benefits

• Potential for conversion to a permanent position

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level